A Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia

Study Overview
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Brief Summary
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This study is examining the efficacy of PF-03463275 compared to placebo in treating negative symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients with schizophrenia.

Detailed Description
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The study was terminated on August 25, 2010 because the study's scientific validity could no longer be supported. The decision to terminate the trial was not based on any safety concerns.

Official Title
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A Randomized Phase 2, Double-Blind, Placebo-Controlled, Multi-Center Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia Treated With A Stable Dose Of A Second Generation Antipsychotic

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: PF-03463275
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have a current diagnosis of schizophrenia of paranoid (295.30), disorganized (295.10), or undifferentiated (295.90) subtype in the residual phase. Subjects must be in ongoing maintenance antipsychotic monotherapy with risperidone, olanzapine, quetiapine, ziprasidone, paliperidone, or aripiprazole. Subjects must be on a stable medication treatment regimen for at least 2 months. Evidence of stable symptomatology at least 3 months. Exclusion Criteria: Female subjects who are pregnant or breastfeeding. Subjects with evidence or history of a clinically significant medical condition which would increase risk or which could interfere with the interpretation of trial results. Subjects who have DSM IV defined psychoactive substance dependence (including alcohol and excluding nicotine and caffeine dependence) within 12 months of screening or substance abuse within 3 months prior to screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-03463275<br> | Drug: PF-03463275<br>* 30 mg Controlled Release tablet BID for 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo tablet BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale score |  | 12 weeks | 
| Vital Signs (Blood pressure, heart rate) |  | 15 weeks | 
| ECG |  | 15 weeks | 
| Safety laboratory assessments |  | 15 weeks | 
| Adverse events |  | 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Quality of Life Scale (QLS) |  | 12 weeks | 
| Change from baseline in MATRICS Composite Cognition Battery (MCCB) composite and individual cognition domain scores |  | 12 weeks | 
| Change from baseline in PANSS Total |  | 12 weeks | 
| Change from baseline in PANSS Positive Subscale |  | 12 weeks | 
| Change from baseline in PANSS General Subscale |  | 12 weeks | 
| Change from baseline in Clinical Global Impression Severity (CGI-S) |  | 12 weeks | 
| Clinical Global Impression Improvement (CGI-I) Total Score |  | 12 weeks | 
| Change from baseline in Scale for Assessment of Negative Symptoms (SANS), modified |  | 12 weeks | 
| Change from baseline in Abbreviated Extrapyramidal Symptom Rating Scale |  | 12 weeks | 
| Change from baseline in Global Assessment of Functioning |  | 12 weeks | 
| Columbia-Suicide Severity Rating Scale (C-SSRS) |  | 15 weeks | 
| Pharmacokinetic assays |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia negative symptoms adjunctive