Back to resultsA Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
Primary Purpose
Cognitive Impairment Associated With Schizophrenia (CIAS)
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-04958242
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Impairment Associated With Schizophrenia (CIAS)
Eligibility Criteria
Key Inclusion Criteria:
- Otherwise healthy male and/or female subjects between the ages of 18 and 50 years, inclusive, with Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia of at least 2 years duration as confirmed by the M.I.N.I 7.0 for Psychotic Disorders
- Evidence of stable schizophrenia symptomatology >=3 months (ie, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia).
- Subjects must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for >=2 months prior to Baseline/Day 1, including concomitant psychotropic treatments. Subjects should be on no more than 2 background antipsychotics.
- Subject must have an identified informant
- Subject must reside in a stable living situation for at least 12 weeks prior to Screening.
Key Exclusion Criteria:
- Subjects with a current DSM-5 diagnosis of schizoaffective disorder in the judgment of the investigator.
- Subjects with a current DSM-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator.
- Subjects with a lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, binge-eating disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator.
- Subjects who meet the DSM-5 diagnosis of moderate or severe psychoactive substance use disorder (excluding nicotine dependence) within 12 months of screening on the M.I.N.I 7.0 for Psychotic Disorders interview and as determined by the investigator.
- Subjects with significant extrapyramidal symptoms which have not been stabilized with anticholinergics.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Sites / Locations
- Collaborative Neuroscience Network, LLC (Investigator Site File Location)
- Collaborative Neuroscience Network, LLC
- Excell Research, Inc
- NRC Research Institute
- California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
- Collaborative Neuroscience Network, LLC
- Atlanta Center For Medical Research
- Alexian Brothers Centers for Psychiatric Research
- Chinmay K. Patel, D.O.
- Lake Charles Clinical Trials
- CBH Health, LLC
- Hassman Research Institute
- CRI Worldwide, LLC
- Research Strategies of Memphis, LLC
- Pillar Clinical Research, LLC
- Northwest Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
0.15 mg PF-04958242
0.5 mg PF-04958242
Placebo
Arm Description
Participants received 0.15 mg oral capsule, twice daily (BID) for 12 weeks
Participants received 0.5 mg oral capsule, twice daily (BID) for 12 weeks
Participants received matching placebo oral capsule, twice daily (BID) for 12 weeks
Outcomes
Primary Outcome Measures
Change From Baseline in the MCCB (MATRICS Consensus Cognitive Battery) Working Memory Domain to Week 12
The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms.
Change From Baseline in the UPSA-VIM (University of California, San Diego [UCSD] Performance Based Skills Assessment - Validation of Intermediate Measures) to Week 12
The UPSA-VIM is a functional capacity measure of 5 general skills that were previously identified as essential to functioning in the community: general organization, finance, social/communications, transportation, and household chores. The UCSD Performance Based Skills Assessment involves role play tasks that are administered as simulations of events that the person might encounter in the community.
Secondary Outcome Measures
Scale for the Assessment and Rating of Ataxia (SARA)
SARA is a clinical scale that is based on a semi--quantitative assessment of cerebellar ataxia on an impairment level and complements the brief neurological examination. The SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.
Number of Participants With Categorical Results on the Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS responses are mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA). C-SSRS assesses whether participant experienced 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 "aborted attempt", or "interrupted attempt", or "preparatory acts or behavior"); suicidal ideation (Category 4) ("Yes" on "wish to be dead", or "non-specific active suicidal thoughts", or "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent"); self-injurious behavior, no suicidal intent (Category 7) ("Yes" on "has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories was to be assessed.
Change From Baseline in the MCCB Neurocognitive Composite (Excluding Social Cognition Domain) to Week 12
The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms. The MCCB neurocognitive score contains all of the tests and domains of the MCCB composite score with the exception of social cognition.
Change From Baseline in MCCB Overall Composite (Including All 7 Domains) to Week 12
The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms.
Change From Baseline in Each of the 6 Individual MCCB Domain Scores (Excluding MCCB Working Memory) to Week 12
The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms.
Change From Baseline in the SCI-PANSS (Structured Clinical Interview Positive and Negative Symptoms Scale) Total to Week 12
The SCI-PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale; 7 items that make up the Negative Scale; and 16 items that make up the General Psychopathology Scale. The sum of the 30 items is defined as the total score.
Change From Baseline in the SCI-PANSS Positive, Negative and General Psychopathology Subscales to Week 12
The SCI--PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale; 7 items that make up the Negative Scale; and 16 items that make up the General Psychopathology Scale. The Subscale scores are the sum of corresponding individual items.
Change From Baseline in the CGI-S (Clinical Global Impression-Severity) to Week 12
The CGI--S consists of a single 7 point rating score of illness severity. Raters select 1 response based on the following question, "Considering your total clinical experience with this particular population, how mentally ill is your patient at this time?" Scores are: 1=Normal, not ill at all; 2=Borderline mentally ill; 3=Mildly ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; or 7=Among the most severely ill participants.
CGI-I (Clinical Global Impression-Improvement) at Week 12
The CGI-I consists of a single 7 point rating score total improvement, regardless of whether or not the change is due entirely to drug treatment. Raters select 1 response based on the following question, "Compared to your patient's condition at the beginning of treatment, how much has your patient changed?" Scores are: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; or 7=Very much worse. For the CGI-I, the participant's condition at the Day 1 (baseline) visit is the criterion for judging improvement at subsequent visits.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. 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. All AEs (serious and non-serious) occurring following start of treatment or increasing in severity in any period were to be considered as a treatment emergent AE.
Number of Participants With Laboratory Test Abnormalities
Number of participants with laboratory test abnormalities without regard to baseline abnormality is assessed. Laboratory test parameters include hematology, clinical chemistry, urinalysis, follicle stimulating hormone, urine drug screen, and pregnancy test.
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
ECG criteria of potential clinical concern: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): greater than or equal to (>=) 140 milliseconds (msec), >=50% increase from baseline; 2) PR interval (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): >=300 msec, >=25% increase when baseline is greater than (>) 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec; 3) QTcF interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected using Fridericia's formula): absolute value of 450 to less than (<) 480 msec, 480 to <500 msec, >=500 msec; an increase from baseline of 30 to <60 msec or >=60 msec.
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Vital signs criteria of potential clinical concern: 1) systolic blood pressure <90 millimeters of mercury (mm Hg); 2) change from baseline of systolic blood pressure >=30 mm Hg; 3) diastolic blood pressure <50 mm Hg; 4) change from baseline of diastolic blood pressure >=20 mm Hg; 5) supine pulse rate <40 or >120 beats per minute (bpm); 6) standing pulse rate <40 or >140 bpm.
Number of Participants With Abnormalities in Neurological Examination
The extended neurological examination includes observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze-evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination includes an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function is complemented by the Scale for the Assessment and Rating of Ataxia (SARA), a clinical scale based on a semi-quantitative assessment of cerebellar ataxia on an impairment level.
Number of Participants With Abnormalities in Physical Examination
A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination is focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02855411
Brief Title
A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
Official Title
A 12 Week, Phase 2, Randomized, Double-blind, Placebo Controlled, Parallel Group Study To Evaluate The Safety And Efficacy Of Pf-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Terminated prematurely Sept 22, 2016 following an internal portfolio prioritization. It is not due to any safety concern or change in benefit:risk assessment.
Study Start Date
August 29, 2016 (Actual)
Primary Completion Date
September 26, 2016 (Actual)
Study Completion Date
September 26, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether PF-04958242 is safe and effective in the treatment of cognitive dysfunction in schizophrenia subjects
Detailed Description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment Associated With Schizophrenia (CIAS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.15 mg PF-04958242
Arm Type
Experimental
Arm Description
Participants received 0.15 mg oral capsule, twice daily (BID) for 12 weeks
Arm Title
0.5 mg PF-04958242
Arm Type
Experimental
Arm Description
Participants received 0.5 mg oral capsule, twice daily (BID) for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received matching placebo oral capsule, twice daily (BID) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04958242
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Administered as specified in the treatment arm
Intervention Description
placebo, twice daily (BID) for 12 weeks, capsule
Primary Outcome Measure Information:
Title
Change From Baseline in the MCCB (MATRICS Consensus Cognitive Battery) Working Memory Domain to Week 12
Description
The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms.
Time Frame
Baseline, Week 2, Week 6, Week 12
Title
Change From Baseline in the UPSA-VIM (University of California, San Diego [UCSD] Performance Based Skills Assessment - Validation of Intermediate Measures) to Week 12
Description
The UPSA-VIM is a functional capacity measure of 5 general skills that were previously identified as essential to functioning in the community: general organization, finance, social/communications, transportation, and household chores. The UCSD Performance Based Skills Assessment involves role play tasks that are administered as simulations of events that the person might encounter in the community.
Time Frame
Baseline, Week 6, Week 12
Secondary Outcome Measure Information:
Title
Scale for the Assessment and Rating of Ataxia (SARA)
Description
SARA is a clinical scale that is based on a semi--quantitative assessment of cerebellar ataxia on an impairment level and complements the brief neurological examination. The SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.
Time Frame
Baseline, Week 2, Week 6, Week 12
Title
Number of Participants With Categorical Results on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
C-SSRS responses are mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA). C-SSRS assesses whether participant experienced 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 "aborted attempt", or "interrupted attempt", or "preparatory acts or behavior"); suicidal ideation (Category 4) ("Yes" on "wish to be dead", or "non-specific active suicidal thoughts", or "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent"); self-injurious behavior, no suicidal intent (Category 7) ("Yes" on "has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories was to be assessed.
Time Frame
Baseline, followed by weekly (Weeks 1 throughout 12), and 28 days after last dose
Title
Change From Baseline in the MCCB Neurocognitive Composite (Excluding Social Cognition Domain) to Week 12
Description
The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms. The MCCB neurocognitive score contains all of the tests and domains of the MCCB composite score with the exception of social cognition.
Time Frame
Baseline, Week 2, Week 6, Week 12
Title
Change From Baseline in MCCB Overall Composite (Including All 7 Domains) to Week 12
Description
The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms.
Time Frame
Baseline, Week 2, Week 6, Week 12
Title
Change From Baseline in Each of the 6 Individual MCCB Domain Scores (Excluding MCCB Working Memory) to Week 12
Description
The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms.
Time Frame
Baseline, Week 2, Week 6, Week 12
Title
Change From Baseline in the SCI-PANSS (Structured Clinical Interview Positive and Negative Symptoms Scale) Total to Week 12
Description
The SCI-PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale; 7 items that make up the Negative Scale; and 16 items that make up the General Psychopathology Scale. The sum of the 30 items is defined as the total score.
Time Frame
Baseline, Week 2, Week 6, Week 12
Title
Change From Baseline in the SCI-PANSS Positive, Negative and General Psychopathology Subscales to Week 12
Description
The SCI--PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale; 7 items that make up the Negative Scale; and 16 items that make up the General Psychopathology Scale. The Subscale scores are the sum of corresponding individual items.
Time Frame
Baseline, Week 2, Week 6, Week 12
Title
Change From Baseline in the CGI-S (Clinical Global Impression-Severity) to Week 12
Description
The CGI--S consists of a single 7 point rating score of illness severity. Raters select 1 response based on the following question, "Considering your total clinical experience with this particular population, how mentally ill is your patient at this time?" Scores are: 1=Normal, not ill at all; 2=Borderline mentally ill; 3=Mildly ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; or 7=Among the most severely ill participants.
Time Frame
Baseline, Week 2, Week 6, Week 12
Title
CGI-I (Clinical Global Impression-Improvement) at Week 12
Description
The CGI-I consists of a single 7 point rating score total improvement, regardless of whether or not the change is due entirely to drug treatment. Raters select 1 response based on the following question, "Compared to your patient's condition at the beginning of treatment, how much has your patient changed?" Scores are: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; or 7=Very much worse. For the CGI-I, the participant's condition at the Day 1 (baseline) visit is the criterion for judging improvement at subsequent visits.
Time Frame
Week 12
Title
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. 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. All AEs (serious and non-serious) occurring following start of treatment or increasing in severity in any period were to be considered as a treatment emergent AE.
Time Frame
For AEs, the time frame was from taking first dose through and including last visit (28 days after the last dose), up to 113 days. For SAEs, the time frame was from the time that the participant provided informed consent to last visit, up to 143 days.
Title
Number of Participants With Laboratory Test Abnormalities
Description
Number of participants with laboratory test abnormalities without regard to baseline abnormality is assessed. Laboratory test parameters include hematology, clinical chemistry, urinalysis, follicle stimulating hormone, urine drug screen, and pregnancy test.
Time Frame
Screening up to Week 12 or early termination
Title
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Description
ECG criteria of potential clinical concern: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): greater than or equal to (>=) 140 milliseconds (msec), >=50% increase from baseline; 2) PR interval (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): >=300 msec, >=25% increase when baseline is greater than (>) 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec; 3) QTcF interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected using Fridericia's formula): absolute value of 450 to less than (<) 480 msec, 480 to <500 msec, >=500 msec; an increase from baseline of 30 to <60 msec or >=60 msec.
Time Frame
Screening up to Week 12 or early termination
Title
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Description
Vital signs criteria of potential clinical concern: 1) systolic blood pressure <90 millimeters of mercury (mm Hg); 2) change from baseline of systolic blood pressure >=30 mm Hg; 3) diastolic blood pressure <50 mm Hg; 4) change from baseline of diastolic blood pressure >=20 mm Hg; 5) supine pulse rate <40 or >120 beats per minute (bpm); 6) standing pulse rate <40 or >140 bpm.
Time Frame
Screening up to Week 12 or early termination
Title
Number of Participants With Abnormalities in Neurological Examination
Description
The extended neurological examination includes observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze-evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination includes an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function is complemented by the Scale for the Assessment and Rating of Ataxia (SARA), a clinical scale based on a semi-quantitative assessment of cerebellar ataxia on an impairment level.
Time Frame
Screening up to Week 12 or early termination
Title
Number of Participants With Abnormalities in Physical Examination
Description
A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination is focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.
Time Frame
Screening up to Week 12 or early termination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Otherwise healthy male and/or female subjects between the ages of 18 and 50 years, inclusive, with Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia of at least 2 years duration as confirmed by the M.I.N.I 7.0 for Psychotic Disorders
Evidence of stable schizophrenia symptomatology >=3 months (ie, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia).
Subjects must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for >=2 months prior to Baseline/Day 1, including concomitant psychotropic treatments. Subjects should be on no more than 2 background antipsychotics.
Subject must have an identified informant
Subject must reside in a stable living situation for at least 12 weeks prior to Screening.
Key Exclusion Criteria:
Subjects with a current DSM-5 diagnosis of schizoaffective disorder in the judgment of the investigator.
Subjects with a current DSM-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator.
Subjects with a lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, binge-eating disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator.
Subjects who meet the DSM-5 diagnosis of moderate or severe psychoactive substance use disorder (excluding nicotine dependence) within 12 months of screening on the M.I.N.I 7.0 for Psychotic Disorders interview and as determined by the investigator.
Subjects with significant extrapyramidal symptoms which have not been stabilized with anticholinergics.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Collaborative Neuroscience Network, LLC (Investigator Site File Location)
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Excell Research, Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Atlanta Center For Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Alexian Brothers Centers for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Chinmay K. Patel, D.O.
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
CBH Health, LLC
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
CRI Worldwide, LLC
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Research Strategies of Memphis, LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Pillar Clinical Research, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
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