Clinical Trials/NCT00977522

NCT00977522

Terminated

Phase 2

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

Pfizer1 site in 1 country207 target enrollmentNovember 2009

ConditionsSchizophrenia

InterventionsPF-03463275 Placebo

DrugsPF-03463275 Placebo

Overview

Phase: Phase 2
Intervention: PF-03463275
Conditions: Schizophrenia
Sponsor: Pfizer
Enrollment: 207
Locations: 1
Primary Endpoint: Change from baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale score
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

September 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

PF-03463275

Intervention: PF-03463275

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change from baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale score

Time Frame: 12 weeks

Vital Signs (Blood pressure, heart rate)

Time Frame: 15 weeks

ECG

Time Frame: 15 weeks

Safety laboratory assessments

Time Frame: 15 weeks

Adverse events

Time Frame: 15 weeks

Secondary Outcomes

Change from baseline in PANSS General Subscale(12 weeks)
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 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)