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NCT00977522 Clinical Trial

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

Schizophrenia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00977522
Other study ID # A9131005
Secondary ID
Status Terminated
Phase Phase 2
First received September 14, 2009
Last updated February 2, 2012
Start date November 2009
Est. completion date September 2010

Study information
Verified date February 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 207
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PF-03463275
30 mg Controlled Release tablet BID for 12 weeks
• Placebo
Placebo tablet BID

Locations
Country Name City State
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Bellaire Texas
United States Pfizer Investigational Site Cerritos California
United States Pfizer Investigational Site Chula Vista California
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Edmond Oklahoma
United States Pfizer Investigational Site Escondido California
United States Pfizer Investigational Site Flowood Mississippi
United States Pfizer Investigational Site Fresh Meadows New York
United States Pfizer Investigational Site Garden Grove California
United States Pfizer Investigational Site Glendale California
United States Pfizer Investigational Site Holliswood New York
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Long Beach California
United States Pfizer Investigational Site Long Beach California
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site National City California
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Paramount California
United States Pfizer Investigational Site Park Ridge Illinois
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Runnemede New Jersey
United States Pfizer Investigational Site Staten Island New York
United States Pfizer Investigational Site Staten Island New York
United States Pfizer Investigational Site Toms River New Jersey
United States Pfizer Investigational Site Torrance California
United States Pfizer Investigational Site Washington District of Columbia
United States Pfizer Investigational Site Washington District of Columbia
United States Pfizer Investigational Site Wichita Kansas
United States Pfizer Investigational Site Wichita Kansas
United States Pfizer Investigational Site Willingboro New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale score 12 weeks No
Primary Vital Signs (Blood pressure, heart rate) 15 weeks Yes
Primary ECG 15 weeks Yes
Primary Safety laboratory assessments 15 weeks Yes
Primary Adverse events 15 weeks Yes
Secondary Change from baseline in Quality of Life Scale (QLS) 12 weeks No
Secondary Change from baseline in MATRICS Composite Cognition Battery (MCCB) composite and individual cognition domain scores 12 weeks No
Secondary Change from baseline in PANSS Total 12 weeks No
Secondary Change from baseline in PANSS Positive Subscale 12 weeks No
Secondary Change from baseline in PANSS General Subscale 12 weeks No
Secondary Change from baseline in Clinical Global Impression Severity (CGI-S) 12 weeks No
Secondary Clinical Global Impression Improvement (CGI-I) Total Score 12 weeks No
Secondary Change from baseline in Scale for Assessment of Negative Symptoms (SANS), modified 12 weeks No
Secondary Change from baseline in Abbreviated Extrapyramidal Symptom Rating Scale 12 weeks Yes
Secondary Change from baseline in Global Assessment of Functioning 12 weeks No
Secondary Columbia-Suicide Severity Rating Scale (C-SSRS) 15 weeks Yes
Secondary Pharmacokinetic assays 12 weeks No
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