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Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

armodafinil

placebo

armodafinil

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria and the patient has been clinically stable in a nonacute phase of their illness.
Documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit.
The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator.
Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence.
The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits.

Key Exclusion Criteria:

The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale.
The patient has any Axis I disorder according to DSM-IV-TR criteria, including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study.
The patient has moderate to severe depressive symptoms, as indicated by the CDSS.
The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
The patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder.
The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies.
The patient is a pregnant or lactating woman.
The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

150 mg/day armodafinil

200 mg/day armodafinil

250 mg/day armodafinil

Matching Placebo

Arm Description

At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.

Outcomes

Primary Outcome Measures

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint

PANSS rates severity of psychopathology in schizophrenics. 7 items measure NEGATIVE symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Negative Scale score ranges from 7-49 (higher more severe). Data represents change in Negative Rating Scale from baseline to endpoint with positive scores indicating more severe pathology.

Secondary Outcome Measures

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents change in total score from baseline to endpoint, higher (positive) scores indicate more severe pathology.

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1

PANSS rates severity of psychopathology in schizophrenics. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg.anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. The data here represents the change in total score from baseline to week 1 and higher (positive) scores indicate more severe pathology.

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 2, higher (positive) scores indicate more severe pathology.

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 4, higher (positive) scores indicate more severe pathology.

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 8, higher (positive) scores indicate more severe pathology.

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 12, higher (positive) scores indicate more severe pathology.

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 16, higher (positive) scores indicate more severe pathology.

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 20, higher (positive) scores indicate more severe pathology.

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 24, higher (positive) scores indicate more severe pathology.

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 1. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 2. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 4. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 8. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 12. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 16. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 20. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 24. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Mean Change From Baseline to Endpoint in the Positive and Negative Syndrome Scale(PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to endpoint. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Mean Change From Baseline to Week 1 in the Positive and Negative Syndrome Scale (PANSS)Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 1. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Mean Change From Baseline to Week 2 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 2. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Mean Change From Baseline to Week 4 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 4. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Mean Change From Baseline to Week 8 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 8. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Mean Change From Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 12. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Mean Change From Baseline to Week 16 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 16. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Mean Change From Baseline to Week 20 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 20. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Mean Change From Baseline to Week 24 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 24. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Mean Change From Baseline to Endpoint on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data shows change from baseline to endpoint.

Mean Change From Baseline to Week 1 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Mean Change From Baseline to Week 2 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Mean Change From Baseline to Week 4 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Mean Change From Baseline to Week 8 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Mean Change From Baseline to Week 12 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Mean Change From Baseline to Week 16 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Mean Change From Baseline to Week 20 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Mean Change From Baseline to Week 24 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Mean Change From Baseline to Endpoint From Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to endpoint.

Mean Change From Baseline to Week 1 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 2 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 4 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 8 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 12 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 16 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 20 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 24 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Endpoint of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item scored on 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to endpoint.

Mean Change From Baseline to Week 1 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in patients with schizophrenia. Positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 1.

Mean Change From Baseline to Week 2 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 2.

Mean Change From Baseline to Week 4 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 8 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 12 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 16 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 20 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 24 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Endpoint From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) scores indicate worsening.

Mean Change From Baseline to Week 1 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) scores indicate worsening.

Mean Change From Baseline to Week 2 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) scores indicate worsening.

Mean Change From Baseline to Week 4 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) scores indicate worsening.

Mean Change From Baseline to Week 8 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) scores indicate worsening.

Mean Change From Baseline to Week 12 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) scores indicate worsening.

Mean Change From Baseline to Week 16 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) scores indicate worsening.

Mean Change From Baseline to Week 20 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) scores indicate worsening.

Mean Change From Baseline to Week 24 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) scores indicate worsening.

Mean Change From Baseline to Endpoint From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in schizophrenic patients. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms/posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to endpoint.

Mean Change From Baseline to Week 1 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 1.

Mean Change From Baseline to Week 2 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 4 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 8 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 12 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 16 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 20 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Week 24 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Mean Change From Baseline to Endpoint From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) score indicates worsening.

Mean Change From Baseline to Week 1 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) score indicates worsening.

Mean Change From Baseline to Week 2 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) score indicates worsening.

Mean Change From Baseline to Week 4 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) score indicates worsening.

Mean Change From Baseline to Week 8 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) score indicates worsening.

Mean Change From Baseline to Week 12 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) score indicates worsening.

Mean Change From Baseline to Week 16 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) score indicates worsening.

Mean Change From Baseline to Week 20 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) score indicates worsening.

Mean Change From Baseline to Week 24 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) score indicates worsening.

Change From Baseline to Endpoint in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to endpoint in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 1 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 1 in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 2 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 2 in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 4 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 4 in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 6 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 6 in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 8 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 8 in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 10 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 10 in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 12 in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 14 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 14 in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 16 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 16 in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 18 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 18 in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 20 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 20 in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 22 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 22 in the CGI-S rating. A negative value indicates improvement.

Change From Baseline to Week 24 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 24 in the CGI-S rating. A negative value indicates improvement.

Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Scores

PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to endpoint in the overall score with positive values signifying improvement.

Mean Change From Baseline to Week 4 in Personal and Social Performance Scale (PSP) Scores

PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 4 in the overall score with positive values signifying improvement.

Mean Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Scores

PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 12 in the overall score with positive values signifying improvement.

Mean Change From Baseline to Week 24 in Personal and Social Performance Scale (PSP) Scores

PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 24 in the overall score with positive values signifying improvement.

Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test

CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate "hits", correct immediate "passes", correct delayed "hits", and correct delayed "passes". Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to endpoint, with positive score showing improvement.

Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test

Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test

Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test (SDCT)

Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to endpoint with positive values representing improvement.

Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test

Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 12 with positive values representing improvement.

Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test

Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 24 with positive values representing improvement.

Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test

The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to endpoint and a positive value represents improvement.

Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test

The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 12 and a positive value represents improvement.

Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test

The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 24 and a positive value represents improvement.

Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]

The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to endpoint with positive values demonstrating improvement.

Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]

The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 12 with positive values demonstrating improvement.

Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]

The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 24 with positive values demonstrating improvement.

Changes From Baseline to Endpoint in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to endpoint, positive value represents worsening.

Changes From Baseline to Week 1 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Changes From Baseline to Week 2 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Changes From Baseline to Week 4 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Changes From Baseline to Week 8 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Changes From Baseline to Week 12 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Changes From Baseline to Week 16 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Changes From Baseline to Week 20 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Changes From Baseline to Week 24 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Changes From Baseline to Endpoint in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to endpoint, positive values represent worsening.

Changes From Baseline to Week 1 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Changes From Baseline to Week 2 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Changes From Baseline to Week 4 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Changes From Baseline to Week 8 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Changes From Baseline to Week 12 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Changes From Baseline to Week 16 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Changes From Baseline to Week 20 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Changes From Baseline to Week 24 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Change From Baseline to Endpoint in the Barnes Akathisia Rating Scale (BARS) Total Score

Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to endpoint, positive values represent worsening.

Change From Baseline to Week 1 in the Barnes Akathisia Rating Scale (BARS) Total Score

Change From Baseline to Week 2 in the Barnes Akathisia Rating Scale (BARS) Total Score

Change From Baseline to Week 4 in the Barnes Akathisia Rating Scale (BARS) Total Score

Change From Baseline to Week 8 in the Barnes Akathisia Rating Scale (BARS) Total Score

Change From Baseline to Week 12 in the Barnes Akathisia Rating Scale (BARS) Total Score

Change From Baseline to Week 16 in the Barnes Akathisia Rating Scale (BARS) Total Score

Change From Baseline to Week 20 in the Barnes Akathisia Rating Scale (BARS) Total Score

Change From Baseline to Week 24 in the Barnes Akathisia Rating Scale (BARS) Total Score

Change From Baseline to Endpoint in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint, positive values represent worsening.

Change From Baseline to Week 1 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Change From Baseline to Week 2 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Change From Baseline to Week 4 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Change From Baseline to Week 8 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Change From Baseline to Week 12 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Change From Baseline to Week 16 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Change From Baseline to Week 20 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Change From Baseline to Week 24 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Endpoint

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 8

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior at week 8 in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 16

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 24

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Endpoint

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at endpoint.

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 8

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 8.

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 16

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 24

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.

Change From Baseline to Endpoint in Sleep Latency

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.

Change From Baseline to Week 12 in Sleep Latency

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.

Change From Baseline to Week 24 in Sleep Latency

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.

Change From Baseline to Endpoint in Number of Nighttime Awakenings

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.

Change From Baseline to Week 12 in Number of Nighttime Awakenings

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.

Change From Baseline to Week 24 in Number of Nighttime Awakenings

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.

Change From Baseline to Endpoint in Time Spent Awake at Night

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent awake at night. A positive value represents longer period awake at night.

Change From Baseline to Week 12 in Time Spent Awake at Night

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent awake at night. A positive value represents longer period awake at night.

Change From Baseline to Week 24 in Time Spent Awake at Night

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent awake at night. A positive value represents longer period awake at night.

Change From Baseline to Endpoint in Time Spent Asleep at Night

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.

Change From Baseline to Week 12 in Time Spent Asleep at Night

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.

Change From Baseline to Week 24 in Time Spent Asleep at Night

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.

Change From Baseline to Endpoint in Sleep Quality Rating

A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.

Change From Baseline to Week 12 in Sleep Quality Rating

A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.

Change From Baseline to Week 24 in Sleep Quality Rating

A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.

Full Information

NCT ID

NCT00772005

First Posted

October 10, 2008

Last Updated

June 21, 2012

Sponsor

Cephalon

1. Study Identification

Unique Protocol Identification Number

NCT00772005

Brief Title

Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia

Official Title

A 24-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil (150, 200, and 250 mg/ Day) as Adjunctive Therapy in Adults With Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cephalon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of the study is to evaluate whether armodafinil treatment is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of schizophrenia

Detailed Description

This study was designed and was powered to evaluate the efficacy and safety of armodafinil treatment at dosages of 150, 200, and 250 mg/day compared with placebo over 24 weeks as an adjunctive therapy to antipsychotic medication (olanzapine, oral risperidone, or paliperidone) in adults with schizophrenia who were clinically stable at study entry. Specifically, the effects of armodafinil treatment on the negative symptoms of schizophrenia were the primary assessment in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

287 (Actual)

8. Arms, Groups, and Interventions

Arm Title

150 mg/day armodafinil

Arm Type

Active Comparator

Arm Description

Arm Title

200 mg/day armodafinil

Arm Type

Active Comparator

Arm Description

Arm Title

250 mg/day armodafinil

Arm Type

Active Comparator

Arm Description

Arm Title

Matching Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

armodafinil

Other Intervention Name(s)

R-modafinil, CEP-10953

Intervention Description

150 mg/day armodafinil

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo

Intervention Type

Drug

Intervention Name(s)

armodafinil

Other Intervention Name(s)

R-modafinil, CEP-10953

Intervention Description

200 mg/day armodafinil

Intervention Type

Drug

Intervention Name(s)

armodafinil

Other Intervention Name(s)

R-modafinil, CEP-10953

Intervention Description

250 mg/day armodafinil

Primary Outcome Measure Information:

Title

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation after baseline)

Secondary Outcome Measure Information:

Title

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation after baseline)

Title

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1

Description

Time Frame

Baseline and Week 1

Title

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2

Description

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 2, higher (positive) scores indicate more severe pathology.

Time Frame

Baseline and Week 2

Title

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4

Description

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 4, higher (positive) scores indicate more severe pathology.

Time Frame

Baseline and Week 4

Title

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8

Description

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 8, higher (positive) scores indicate more severe pathology.

Time Frame

Baseline and Week 8

Title

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12

Description

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 12, higher (positive) scores indicate more severe pathology.

Time Frame

Baseline and Week 12

Title

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16

Description

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 16, higher (positive) scores indicate more severe pathology.

Time Frame

Baseline and Week 16

Title

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20

Description

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 20, higher (positive) scores indicate more severe pathology.

Time Frame

Baseline and Week 20

Title

Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24

Description

PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 24, higher (positive) scores indicate more severe pathology.

Time Frame

Baseline and Week 24

Title

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1

Description

Time Frame

Baseline and Week 1

Title

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2

Description

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 2. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Time Frame

Baseline and Week 2

Title

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4

Description

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 4. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Time Frame

Baseline and Week 4

Title

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8

Description

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 8. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Time Frame

Baseline and Week 8

Title

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12

Description

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 12. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Time Frame

Baseline and Week 12

Title

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16

Description

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 16. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Time Frame

Baseline and Week 16

Title

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20

Description

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 20. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Time Frame

Baseline and Week 20

Title

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24

Description

PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 24. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.

Time Frame

Baseline and Week 24

Title

Mean Change From Baseline to Endpoint in the Positive and Negative Syndrome Scale(PANSS) Positive Scale Score

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Mean Change From Baseline to Week 1 in the Positive and Negative Syndrome Scale (PANSS)Positive Scale Score

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 1. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Time Frame

Baseline and Week 1

Title

Mean Change From Baseline to Week 2 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 2. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Time Frame

Baseline and Week 2

Title

Mean Change From Baseline to Week 4 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 4. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Time Frame

Baseline and Week 4

Title

Mean Change From Baseline to Week 8 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 8. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Time Frame

Baseline and Week 8

Title

Mean Change From Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 12. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Time Frame

Baseline and Week 12

Title

Mean Change From Baseline to Week 16 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 16. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Time Frame

Baseline and Week 16

Title

Mean Change From Baseline to Week 20 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 20. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Time Frame

Baseline and Week 20

Title

Mean Change From Baseline to Week 24 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 24. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.

Time Frame

Baseline and Week 24

Title

Mean Change From Baseline to Endpoint on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation after baseline)

Title

Mean Change From Baseline to Week 1 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Description

Time Frame

Baseline and Week 1

Title

Mean Change From Baseline to Week 2 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Description

Time Frame

Baseline and Week 2

Title

Mean Change From Baseline to Week 4 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Description

Time Frame

Baseline and Week 4

Title

Mean Change From Baseline to Week 8 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Description

Time Frame

Baseline and Week 8

Title

Mean Change From Baseline to Week 12 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Description

Time Frame

Baseline and Week 12

Title

Mean Change From Baseline to Week 16 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Description

Time Frame

Baseline and Week 16

Title

Mean Change From Baseline to Week 20 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Description

Time Frame

Baseline and Week 20

Title

Mean Change From Baseline to Week 24 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score

Description

Time Frame

Baseline and Week 24

Title

Mean Change From Baseline to Endpoint From Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Mean Change From Baseline to Week 1 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 1

Title

Mean Change From Baseline to Week 2 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 2

Title

Mean Change From Baseline to Week 4 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 4

Title

Mean Change From Baseline to Week 8 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 8

Title

Mean Change From Baseline to Week 12 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 12

Title

Mean Change From Baseline to Week 16 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 16

Title

Mean Change From Baseline to Week 20 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 20

Title

Mean Change From Baseline to Week 24 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 24

Title

Mean Change From Baseline to Endpoint of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Mean Change From Baseline to Week 1 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 1

Title

Mean Change From Baseline to Week 2 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 2

Title

Mean Change From Baseline to Week 4 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 4

Title

Mean Change From Baseline to Week 8 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 8

Title

Mean Change From Baseline to Week 12 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 12

Title

Mean Change From Baseline to Week 16 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 16

Title

Mean Change From Baseline to Week 20 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 20

Title

Mean Change From Baseline to Week 24 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 24

Title

Mean Change From Baseline to Endpoint From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Mean Change From Baseline to Week 1 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) scores indicate worsening.

Time Frame

Baseline and Week 1

Title

Mean Change From Baseline to Week 2 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) scores indicate worsening.

Time Frame

Baseline and Week 2

Title

Mean Change From Baseline to Week 4 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) scores indicate worsening.

Time Frame

Baseline and Week 4

Title

Mean Change From Baseline to Week 8 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) scores indicate worsening.

Time Frame

Baseline and Week 8

Title

Mean Change From Baseline to Week 12 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) scores indicate worsening.

Time Frame

Baseline and Week 12

Title

Mean Change From Baseline to Week 16 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) scores indicate worsening.

Time Frame

Baseline and Week 16

Title

Mean Change From Baseline to Week 20 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) scores indicate worsening.

Time Frame

Baseline and Week 20

Title

Mean Change From Baseline to Week 24 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) scores indicate worsening.

Time Frame

Baseline and Week 24

Title

Mean Change From Baseline to Endpoint From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Mean Change From Baseline to Week 1 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 1

Title

Mean Change From Baseline to Week 2 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 2

Title

Mean Change From Baseline to Week 4 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 4

Title

Mean Change From Baseline to Week 8 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 8

Title

Mean Change From Baseline to Week 12 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 12

Title

Mean Change From Baseline to Week 16 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 16

Title

Mean Change From Baseline to Week 20 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 20

Title

Mean Change From Baseline to Week 24 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Week 24

Title

Mean Change From Baseline to Endpoint From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Mean Change From Baseline to Week 1 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) score indicates worsening.

Time Frame

Baseline and Week 1

Title

Mean Change From Baseline to Week 2 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) score indicates worsening.

Time Frame

Baseline and Week 2

Title

Mean Change From Baseline to Week 4 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) score indicates worsening.

Time Frame

Baseline and Week 4

Title

Mean Change From Baseline to Week 8 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) score indicates worsening.

Time Frame

Baseline and Week 8

Title

Mean Change From Baseline to Week 12 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) score indicates worsening.

Time Frame

Baseline and Week 12

Title

Mean Change From Baseline to Week 16 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) score indicates worsening.

Time Frame

Baseline and Week 16

Title

Mean Change From Baseline to Week 20 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) score indicates worsening.

Time Frame

Baseline and Week 20

Title

Mean Change From Baseline to Week 24 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)

Description

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) score indicates worsening.

Time Frame

Baseline and Week 24

Title

Change From Baseline to Endpoint in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Change From Baseline to Week 1 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 1 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 1

Title

Change From Baseline to Week 2 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 2 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 2

Title

Change From Baseline to Week 4 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 4 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 4

Title

Change From Baseline to Week 6 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 6 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 6

Title

Change From Baseline to Week 8 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 8 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 8

Title

Change From Baseline to Week 10 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 10 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 10

Title

Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 12 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 14 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 14 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 14

Title

Change From Baseline to Week 16 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 16 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 16

Title

Change From Baseline to Week 18 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 18 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 18

Title

Change From Baseline to Week 20 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 20 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 20

Title

Change From Baseline to Week 22 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 22 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 22

Title

Change From Baseline to Week 24 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating

Description

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 24 in the CGI-S rating. A negative value indicates improvement.

Time Frame

Baseline and Week 24

Title

Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Scores

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Mean Change From Baseline to Week 4 in Personal and Social Performance Scale (PSP) Scores

Description

PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 4 in the overall score with positive values signifying improvement.

Time Frame

Baseline and Week 4

Title

Mean Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Scores

Description

PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 12 in the overall score with positive values signifying improvement.

Time Frame

Baseline and Week 12

Title

Mean Change From Baseline to Week 24 in Personal and Social Performance Scale (PSP) Scores

Description

PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 24 in the overall score with positive values signifying improvement.

Time Frame

Baseline and Week 24

Title

Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test

Description

Time Frame

Baseline and Week 12

Title

Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test

Description

Time Frame

Baseline and Week 24

Title

Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test (SDCT)

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test

Description

Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 12 with positive values representing improvement.

Time Frame

Baseline and Week 12

Title

Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test

Description

Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 24 with positive values representing improvement.

Time Frame

Baseline and Week 24

Title

Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test

Description

The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 12 and a positive value represents improvement.

Time Frame

Baseline and Week 12

Title

Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test

Description

The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 24 and a positive value represents improvement.

Time Frame

Baseline and Week 24

Title

Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]

Description

The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 12 with positive values demonstrating improvement.

Time Frame

Baseline and Week 12

Title

Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]

Description

The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 24 with positive values demonstrating improvement.

Time Frame

Baseline and Week 24

Title

Changes From Baseline to Endpoint in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Changes From Baseline to Week 1 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Description

Time Frame

Baseline and Week 1

Title

Changes From Baseline to Week 2 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Description

Time Frame

Baseline and Week 2

Title

Changes From Baseline to Week 4 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Description

Time Frame

Baseline and Week 4

Title

Changes From Baseline to Week 8 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Description

Time Frame

Baseline and Week 8

Title

Changes From Baseline to Week 12 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Description

Time Frame

Baseline and Week 12

Title

Changes From Baseline to Week 16 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Description

Time Frame

Baseline and Week 16

Title

Changes From Baseline to Week 20 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Description

Time Frame

Baseline and Week 20

Title

Changes From Baseline to Week 24 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores

Description

Time Frame

Baseline and Week 24

Title

Changes From Baseline to Endpoint in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Changes From Baseline to Week 1 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Description

Time Frame

Baseline and Week 1

Title

Changes From Baseline to Week 2 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Description

Time Frame

Baseline and Week 2

Title

Changes From Baseline to Week 4 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Description

Time Frame

Baseline and Week 4

Title

Changes From Baseline to Week 8 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Description

Time Frame

Baseline and Week 8

Title

Changes From Baseline to Week 12 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Description

Time Frame

Baseline and Week 12

Title

Changes From Baseline to Week 16 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Description

Time Frame

Baseline and Week 16

Title

Changes From Baseline to Week 20 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Description

Time Frame

Baseline and Week 20

Title

Changes From Baseline to Week 24 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline to Endpoint in the Barnes Akathisia Rating Scale (BARS) Total Score

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Change From Baseline to Week 1 in the Barnes Akathisia Rating Scale (BARS) Total Score

Description

Time Frame

Baseline and Week 1

Title

Change From Baseline to Week 2 in the Barnes Akathisia Rating Scale (BARS) Total Score

Description

Time Frame

Baseline and Week 2

Title

Change From Baseline to Week 4 in the Barnes Akathisia Rating Scale (BARS) Total Score

Description

Time Frame

Baseline and Week 4

Title

Change From Baseline to Week 8 in the Barnes Akathisia Rating Scale (BARS) Total Score

Description

Time Frame

Baseline and Week 8

Title

Change From Baseline to Week 12 in the Barnes Akathisia Rating Scale (BARS) Total Score

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 16 in the Barnes Akathisia Rating Scale (BARS) Total Score

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline to Week 20 in the Barnes Akathisia Rating Scale (BARS) Total Score

Description

Time Frame

Baseline and Week 20

Title

Change From Baseline to Week 24 in the Barnes Akathisia Rating Scale (BARS) Total Score

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline to Endpoint in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Change From Baseline to Week 1 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Description

Time Frame

Baseline and Week 1

Title

Change From Baseline to Week 2 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Description

Time Frame

Baseline and Week 2

Title

Change From Baseline to Week 4 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Description

Time Frame

Baseline and Week 4

Title

Change From Baseline to Week 8 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Description

Time Frame

Baseline and Week 8

Title

Change From Baseline to Week 12 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 16 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline to Week 20 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Description

Time Frame

Baseline and Week 20

Title

Change From Baseline to Week 24 in the Calgary Depression Scale for Schizophrenia (CDSS) Score

Description

Time Frame

Baseline and Week 24

Title

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Endpoint

Description

Time Frame

Endpoint (Week 24 or last observation)

Title

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 8

Description

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior at week 8 in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.

Time Frame

Week 8

Title

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 16

Description

Time Frame

Week 16

Title

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 24

Description

Time Frame

Week 24

Title

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Endpoint

Description

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at endpoint.

Time Frame

Endpoint (Week 24 or last observation)

Title

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 8

Description

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 8.

Time Frame

Week 8

Title

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 16

Description

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.

Time Frame

Week 16

Title

Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 24

Description

The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.

Time Frame

Week 24

Title

Change From Baseline to Endpoint in Sleep Latency

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Change From Baseline to Week 12 in Sleep Latency

Description

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 24 in Sleep Latency

Description

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.

Time Frame

Baseline and Week 24

Title

Change From Baseline to Endpoint in Number of Nighttime Awakenings

Description

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Change From Baseline to Week 12 in Number of Nighttime Awakenings

Description

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 24 in Number of Nighttime Awakenings

Description

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.

Time Frame

Baseline and Week 24

Title

Change From Baseline to Endpoint in Time Spent Awake at Night

Description

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent awake at night. A positive value represents longer period awake at night.

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Change From Baseline to Week 12 in Time Spent Awake at Night

Description

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent awake at night. A positive value represents longer period awake at night.

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 24 in Time Spent Awake at Night

Description

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent awake at night. A positive value represents longer period awake at night.

Time Frame

Baseline and Week 24

Title

Change From Baseline to Endpoint in Time Spent Asleep at Night

Description

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Change From Baseline to Week 12 in Time Spent Asleep at Night

Description

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 24 in Time Spent Asleep at Night

Description

A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.

Time Frame

Baseline and Week 24

Title

Change From Baseline to Endpoint in Sleep Quality Rating

Description

Time Frame

Baseline and Endpoint (Week 24 or last observation)

Title

Change From Baseline to Week 12 in Sleep Quality Rating

Description

A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.

Time Frame

Baseline and Week 12

Title

Change From Baseline to Week 24 in Sleep Quality Rating

Description

A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.

Time Frame

Baseline and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria and the patient has been clinically stable in a nonacute phase of their illness. Documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit. The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator. Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence. The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits. Key Exclusion Criteria: The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale. The patient has any Axis I disorder according to DSM-IV-TR criteria, including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study. The patient has moderate to severe depressive symptoms, as indicated by the CDSS. The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present. The patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder. The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies. The patient is a pregnant or lactating woman. The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sponsor's Medical Expert

Organizational Affiliation

Cephalon

Official's Role

Study Director

Facility Information:

Facility Name

K and S Professional Research Services, LLC

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72201

Country

United States

Facility Name

Omega Clinical Trials

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Facility Name

Synergy Clinical Research Center

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Collaborative NeuroScience

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

Excell Research

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

CNRI Los Angeles LLC

City

Pico Rivera

State/Province

California

ZIP/Postal Code

90660

Country

United States

Facility Name

CNRI-San Diego LLC

City

San Diego

State/Province

California

ZIP/Postal Code

92116

Country

United States

Facility Name

Neuropsychiatric Research Center of Orange County

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

Facility Name

Collaborative NeuroScience Network

City

Torrance

State/Province

California

ZIP/Postal Code

33613

Country

United States

Facility Name

The Hospital of Central Connecticut

City

New Britain

State/Province

Connecticut

ZIP/Postal Code

06050

Country

United States

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Facility Name

Scientific Clinical Research, Inc.

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Mental Health Advocates. Inc

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33431

Country

United States

Facility Name

Fidelity Clinical Research

City

Lauderhill

State/Province

Florida

ZIP/Postal Code

33319

Country

United States

Facility Name

Stedman Clinical Trials, LLC

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Atlanta Center for Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Comprehensive Neuroscience Inc

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Carman Research

City

Smyrna

State/Province

Georgia

ZIP/Postal Code

30080

Country

United States

Facility Name

Uptown Research Institute. LLC

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

Via Christi Research

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Lake Charles Clinical Trials

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Clinical Insights

City

Glen Burnie

State/Province

Maryland

ZIP/Postal Code

21061

Country

United States

Facility Name

Sheppard Pratt Health System

City

Towson

State/Province

Maryland

ZIP/Postal Code

21285

Country

United States

Facility Name

St Louis Clinical Trials LC

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63118

Country

United States

Facility Name

CRI Worldwide LLC

City

Clementon

State/Province

New Jersey

ZIP/Postal Code

08021

Country

United States

Facility Name

Behavioral Medical Research of Brooklyn

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

Social Psychiatry Research Institute

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11235

Country

United States

Facility Name

Finger Lakes Clinical Research

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

Behavioral Medical Research of Staten Island

City

Staten Island

State/Province

New York

ZIP/Postal Code

10305

Country

United States

Facility Name

Midwest Clinical Research Center

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45408

Country

United States

Facility Name

Keystone Clinical Studies LLC

City

Norristown

State/Province

Pennsylvania

ZIP/Postal Code

19401

Country

United States

Facility Name

Belmont Center for Comprehensive Treatment

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19131

Country

United States

Facility Name

CRI Worldwide

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19139

Country

United States

Facility Name

Carolina Clinical Trials. Inc

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29405

Country

United States

Facility Name

Community Clinical Research

City

Austin

State/Province

Texas

ZIP/Postal Code

78754

Country

United States

Facility Name

FutureSearch Trials

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

University Hills Clinical Research

City

Irving

State/Province

Texas

ZIP/Postal Code

75062

Country

United States

Facility Name

Alliance Research Group

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23230

Country

United States

Facility Name

Northwest Clinical Research Center

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98004

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22178084

Citation

Kane JM, Yang R, Youakim JM. Adjunctive armodafinil for negative symptoms in adults with schizophrenia: a double-blind, placebo-controlled study. Schizophr Res. 2012 Mar;135(1-3):116-22. doi: 10.1016/j.schres.2011.11.006. Epub 2011 Dec 16.

Results Reference

derived

Learn more about this trial

Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia

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Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia

Schizophrenia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial