Status:
TERMINATED
A Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia
Lead Sponsor:
Pfizer
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 schizoph...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00977522
Start Date
November 1 2009
End Date
September 1 2010
Last Update
February 7 2012
Active Locations (37)
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1
Pfizer Investigational Site
Cerritos, California, United States, 90703
2
Pfizer Investigational Site
Chula Vista, California, United States, 91910
3
Pfizer Investigational Site
Escondido, California, United States, 92025
4
Pfizer Investigational Site
Garden Grove, California, United States, 92845