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

Phase 2

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: PF-03463275

• Registration Number: NCT00977522
• Lead Sponsor: Pfizer

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-09-14
• Study First Submitted QC: 2009-09-14
• Study First Posted: 2009-09-15
• Study Start: 2009-11
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Disposition First Submitted: 2012-01-26
• Status Verified: 2012-02
• Disposition First Submitted QC: 2012-02-02
• Last Update Submitted: 2012-02-02
• Disposition First Posted: 2012-02-07
• Last Update Posted: 2012-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 207

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PF-03463275	PF-03463275	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Houston, Texas, United States