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An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-02545920
Placebo
PF-02545920
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring PF-02545920, schizophrenia, outpatient, safety, efficacy, suboptimal response

Eligibility Criteria

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

Inclusion Criteria:

  • Psychiatrically stable subjects with schizophrenia who have had a suboptimal response to current treatment
  • Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.
  • Subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications.

Exclusion Criteria:

  • History of seizures or of a condition with risk of seizures.
  • Subjects with schizophrenia that have not responded at all to current treatment.
  • Pregnant or nursing females, and females of child bearing potential.

Sites / Locations

  • Birmingham Psychiatry Pharmaceutical Studies, Inc.
  • Woodland International Research Group, INC
  • Comprehensive Clinical Development, Inc.
  • ProScience Research Group
  • Synergy Clinical Research of Escondido
  • Collaborative Neuroscience Network, Inc.
  • Pacific Research Partners
  • Excell Research, Inc.
  • Neuropsychiatric Research Center of Orange County
  • CiTrials
  • CNRI-San Diego, LLC
  • Sharp Mesa Vista Hospital
  • Collaborative Neuroscience Network, Inc.
  • Bliss Basement Pharmacy
  • Institute of Living
  • Yale University
  • Comprehensive Clinical Development
  • Florida Clinical Research Center, LLC
  • Florida Clinical research Center, LLC
  • Innovative Clinical Research, Inc.
  • Medical Research Group of Central Florida
  • Comprehensive Clinical Development, Inc.
  • Alexian Brothers Center for Psychiatric Research
  • Chinmay K. Patel, DO
  • Behavioral Health Care Associates
  • Lake Charles Clinical Trials
  • Louisiana Clinical Research
  • CBH Health, LLC
  • Psychiatric Care & Research Center
  • St. Louis Clinical Trials/The Summit@Creve Coeur
  • Altea Research
  • Comprehensive Clinical Development
  • Manhattan Psychiatric Center's 125th St. Clinic
  • Manhattan Psychiatric Center
  • Midwest Clinical Research Center, LLC
  • Cutting Edge Research Group
  • Research Strategies of Memphis, LLC
  • FutureSearch Trials
  • Community Clinical Research, Inc
  • Futuresearch Trials of Dallas
  • Pillar Clinical Research LLC
  • InSite Clinical Research
  • Psychiatric and Behaviorial Solutions
  • Lifetree Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

PF-02545920 (5mg)

Placebo

PF-02545920 (15mg)

Arm Description

Outcomes

Primary Outcome Measures

Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline
The Positive and Negative Syndrome Scale (PANSS) assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.
Change From Baseline to Week 12 in PANSS Total Score
The PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.

Secondary Outcome Measures

Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score
The Personal and Social Performance Scale (PSP) is a validated clinician-related scale that measured personal and social functioning in the domains of: socially useful activities (eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviors. Information from the participant and the informant were utilized in determining the rating. A PSP total score was determined from the 4 domains (score range 0-100). A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a participant with a score of 30 or less has functioning so poor he or she requires intensive supervision.
Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales
The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity. Total General Psychopathology Subscale score range from 16 to 112; higher score indicates greater severity.
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores
The subscales based on Marder factors are: negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 7 to 49 for negative symptoms, 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for uncontrolled hostility/excitement and anxiety/depression. Higher scores indicate higher severity of symptoms.
Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)
CGI-S: 7-point clinician-rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.
Clinical Global Impression - Improvement (CGI-I) Total Score at Week 12
CGI-I: 7-point clinician-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAEs) were defined as newly occurring AEs or those worsening after first dose.
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or change in sitting, supine and standing SBP of more than or equal to (>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of <50 mm Hg or change in sitting, supine, and standing DBP of >=20 mm Hg; supine and sitting pulse rate of <40 or more than (>)120 beats per minute (bpm); and standing pulse rate of <40 or >140 bpm.
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval >=300 milliseconds (msec) and increase from baseline >=25/50%; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec and increase of >=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to <480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec.
Number of Participants With Weight Change >=7%
The effects of PF-02545920 on body weight were evaluated. The number of participants with changes from baseline in body weight of >=7% were tabulated and summarized.
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site
A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.
Number of Participants With Laboratory Test Abnormalities
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, lipids, electrolytes, hormones (prolactin), clinical chemistry, and urinalysis (dipstick and microscopy).
Number of Participants With Extrapyramidal Motor System (EPS) AEs
EPS AEs consisted of oromandibular dystonia, extrapyramidal disorder, akathisia, dyskinesia, and tremor.
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12
Choleseterol, TG, glycosylated hemoglobin (HbA1c), LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 6 and 12
Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).
Change From Baseline in Insulin at Weeks 6 and 12
Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).
Change From Baseline in Prolactin at Weeks 6 and 12
Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)
The ESRS-A is a 28-item instrument designed to facilitate standardized observations of parkinsonism, dystonia, dyskinesia, and akathisia. Ratings were determined through a combination of clinical interview and a motor examination. Scores were divided into individual domain scores and clinical global impression scores (CGI-S). Scores started from 0 (normal) to 6 (0 to 8 for CGI-S), with higher scores indicating greater severity.
Absolute Values of Movement Disorder Burden Score - Dystonia (MDBS-D) Over Active Treatment Period
The MDBS-D quantified the dystonia burden during the active treatment period. For an individual participant, MDBS-D took into account all treatment-emergent dystonia events and was defined as a combination of the severity of the AE due to dystonia, AE duration, prescribed concomitant medication, and the total number of days the study treatment was received. Scores for the MDBS-D ranged from 0 (no dystonia events) to 4.5, with higher scores indicating greater dystonia burden.
Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS assessed whether participant experienced the following: completed suicide (Category 1), suicide attempt (Category 2; response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Category 3; "Yes" on "preparatory acts or behavior"), suicidal ideation (Category 4; "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (Category 7; "Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Concentration of PF-02545920 and Its Metabolite, PF-01001252
Pharmacokinetic (PK) samples were collected at varying times relative to drug dosing whenever participants could be scheduled for study visits (sparse PK sampling). Thus, because of the variable time between the last dose and the collection of the PK samples, typical summary PK analyses were not planned or described in the study protocol and are not available. The study protocol analysis section specified that the sparse sampled PK data might be pooled with PK data from previous PF-02545920 clinical studies, however the study results did not support conducting those analyses.

Full Information

First Posted
August 9, 2013
Last Updated
July 12, 2016
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01939548
Brief Title
An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia
Official Title
A 12-week , Randomized, Phase 2, Double-blind, Parallel-group Study Of Two Dose Levels Of Pf-02545920 Compared To Placebo In The Adjunctive Treatment Of Outpatients With Sub-optimally Controlled Symptoms Of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
A pre-planned interim analysis indicated the trial was unlikely to meet the pre-specified efficacy criteria. The decision was not based on any safety concerns.
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of sub-optimally controlled symptoms of schizophrenia during a 12-week outpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 from baseline compared to placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
PF-02545920, schizophrenia, outpatient, safety, efficacy, suboptimal response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-02545920 (5mg)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
PF-02545920 (15mg)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-02545920
Other Intervention Name(s)
5 mg BID
Intervention Description
PF-02545920 2 mg BID x 7 days, then 5 mg BID until the Week 12 visit
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo BID until the Week 12 visit
Intervention Type
Drug
Intervention Name(s)
PF-02545920
Other Intervention Name(s)
15 mg BID
Intervention Description
PF-02545920 5 mg BID x 7 days, then 10 mg BID x 7 days, then 15 mg BID until the Week 12 visit
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline
Description
The Positive and Negative Syndrome Scale (PANSS) assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.
Time Frame
Baseline
Title
Change From Baseline to Week 12 in PANSS Total Score
Description
The PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score
Description
The Personal and Social Performance Scale (PSP) is a validated clinician-related scale that measured personal and social functioning in the domains of: socially useful activities (eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviors. Information from the participant and the informant were utilized in determining the rating. A PSP total score was determined from the 4 domains (score range 0-100). A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a participant with a score of 30 or less has functioning so poor he or she requires intensive supervision.
Time Frame
Baseline, Week 12
Title
Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales
Description
The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity. Total General Psychopathology Subscale score range from 16 to 112; higher score indicates greater severity.
Time Frame
Baseline, Week 12
Title
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores
Description
The subscales based on Marder factors are: negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 7 to 49 for negative symptoms, 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for uncontrolled hostility/excitement and anxiety/depression. Higher scores indicate higher severity of symptoms.
Time Frame
Baseline, Week 12
Title
Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)
Description
CGI-S: 7-point clinician-rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.
Time Frame
Baseline, Week 12
Title
Clinical Global Impression - Improvement (CGI-I) Total Score at Week 12
Description
CGI-I: 7-point clinician-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time Frame
Week 12
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
Description
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAEs) were defined as newly occurring AEs or those worsening after first dose.
Time Frame
Baseline up to 7-10 days after last dose of study drug (follow-up)
Title
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Description
Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or change in sitting, supine and standing SBP of more than or equal to (>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of <50 mm Hg or change in sitting, supine, and standing DBP of >=20 mm Hg; supine and sitting pulse rate of <40 or more than (>)120 beats per minute (bpm); and standing pulse rate of <40 or >140 bpm.
Time Frame
Screening up to 7-10 days after last dose of study drug (follow-up)
Title
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
Description
Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval >=300 milliseconds (msec) and increase from baseline >=25/50%; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec and increase of >=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to <480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec.
Time Frame
Screening/Baseline up to Week 12 (or Early Termination)
Title
Number of Participants With Weight Change >=7%
Description
The effects of PF-02545920 on body weight were evaluated. The number of participants with changes from baseline in body weight of >=7% were tabulated and summarized.
Time Frame
Screening up to Day 84
Title
Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site
Description
A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.
Time Frame
Baseline and Week 12 or Early Termination
Title
Number of Participants With Laboratory Test Abnormalities
Description
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, lipids, electrolytes, hormones (prolactin), clinical chemistry, and urinalysis (dipstick and microscopy).
Time Frame
Screening up to Week 12/Early Termination and 7-10 days after last dose of study drug (hematology only)
Title
Number of Participants With Extrapyramidal Motor System (EPS) AEs
Description
EPS AEs consisted of oromandibular dystonia, extrapyramidal disorder, akathisia, dyskinesia, and tremor.
Time Frame
Baseline up to 7-10 days after last dose of study drug (follow-up)
Title
Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12
Description
Choleseterol, TG, glycosylated hemoglobin (HbA1c), LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).
Time Frame
Baseline; Weeks 6 and 12
Title
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 6 and 12
Description
Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).
Time Frame
Baseline; Weeks 6 and 12
Title
Change From Baseline in Insulin at Weeks 6 and 12
Description
Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).
Time Frame
Baseline; Weeks 6 and 12
Title
Change From Baseline in Prolactin at Weeks 6 and 12
Description
Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).
Time Frame
Baseline; Weeks 6 and 12
Title
Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)
Description
The ESRS-A is a 28-item instrument designed to facilitate standardized observations of parkinsonism, dystonia, dyskinesia, and akathisia. Ratings were determined through a combination of clinical interview and a motor examination. Scores were divided into individual domain scores and clinical global impression scores (CGI-S). Scores started from 0 (normal) to 6 (0 to 8 for CGI-S), with higher scores indicating greater severity.
Time Frame
Baseline, Week 12
Title
Absolute Values of Movement Disorder Burden Score - Dystonia (MDBS-D) Over Active Treatment Period
Description
The MDBS-D quantified the dystonia burden during the active treatment period. For an individual participant, MDBS-D took into account all treatment-emergent dystonia events and was defined as a combination of the severity of the AE due to dystonia, AE duration, prescribed concomitant medication, and the total number of days the study treatment was received. Scores for the MDBS-D ranged from 0 (no dystonia events) to 4.5, with higher scores indicating greater dystonia burden.
Time Frame
Active treatment period (Weeks 1 to 12/Early Termination)
Title
Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
C-SSRS assessed whether participant experienced the following: completed suicide (Category 1), suicide attempt (Category 2; response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Category 3; "Yes" on "preparatory acts or behavior"), suicidal ideation (Category 4; "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (Category 7; "Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Time Frame
Baseline up to 7-10 days after last dose of study drug
Title
Concentration of PF-02545920 and Its Metabolite, PF-01001252
Description
Pharmacokinetic (PK) samples were collected at varying times relative to drug dosing whenever participants could be scheduled for study visits (sparse PK sampling). Thus, because of the variable time between the last dose and the collection of the PK samples, typical summary PK analyses were not planned or described in the study protocol and are not available. The study protocol analysis section specified that the sparse sampled PK data might be pooled with PK data from previous PF-02545920 clinical studies, however the study results did not support conducting those analyses.
Time Frame
Days 14, 28, 42, 56, 70, 84/Early Termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Psychiatrically stable subjects with schizophrenia who have had a suboptimal response to current treatment Evidence of stable schizophrenia symptomatology greater than or equal to 3 months. Subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications. Exclusion Criteria: History of seizures or of a condition with risk of seizures. Subjects with schizophrenia that have not responded at all to current treatment. Pregnant or nursing females, and females of child bearing potential.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Psychiatry Pharmaceutical Studies, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States
Facility Name
Woodland International Research Group, INC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Comprehensive Clinical Development, Inc.
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Synergy Clinical Research of Escondido
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Pacific Research Partners
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Excell Research, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
CiTrials
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
CNRI-San Diego, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Bliss Basement Pharmacy
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Institute of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Comprehensive Clinical Development
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Florida Clinical research Center, LLC
City
Brandenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Innovative Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Medical Research Group of Central Florida
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Comprehensive Clinical Development, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Chinmay K. Patel, DO
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Behavioral Health Care Associates
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Louisiana Clinical Research
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
CBH Health, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Psychiatric Care & Research Center
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
St. Louis Clinical Trials/The Summit@Creve Coeur
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Altea Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Comprehensive Clinical Development
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Manhattan Psychiatric Center's 125th St. Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
Manhattan Psychiatric Center
City
Ward's Island
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Midwest Clinical Research Center, LLC
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Research Strategies of Memphis, LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Community Clinical Research, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Futuresearch Trials of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pillar Clinical Research LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Psychiatric and Behaviorial Solutions
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84105
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25554563
Citation
Targum SD, Cara Pendergrass J, Toner C, Zumpano L, Rauh P, DeMartinis N. Impact of BPRS interview length on ratings reliability in a schizophrenia trial. Eur Neuropsychopharmacol. 2015 Mar;25(3):312-8. doi: 10.1016/j.euroneuro.2014.11.023. Epub 2014 Dec 13.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8241019&StudyName=An%20Outpatient%20Study%20Of%20The%20Efficacy%2C%20Safety%2C%20And%20Tolerability%20Of%20PF-02545920%20In%20The%20Adjunctive%20Treatment%20Of%20Sub-Optimally%20Controlled%20S
Description
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Learn more about this trial

An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia

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