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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
207
30 mg Controlled Release tablet BID for 12 weeks
Placebo tablet BID
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
Change from baseline in Quality of Life Scale (QLS)
Time frame: 12 weeks
Change from baseline in MATRICS Composite Cognition Battery (MCCB) composite and individual cognition domain scores
Time frame: 12 weeks
Change from baseline in PANSS Total
Time frame: 12 weeks
Change from baseline in PANSS Positive Subscale
Time frame: 12 weeks
Change from baseline in PANSS General Subscale
Time frame: 12 weeks
Change from baseline in Clinical Global Impression Severity (CGI-S)
Time frame: 12 weeks
Clinical Global Impression Improvement (CGI-I) Total Score
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Pfizer Investigational Site
Cerritos, California, United States
Pfizer Investigational Site
Chula Vista, California, United States
Pfizer Investigational Site
Escondido, California, United States
Pfizer Investigational Site
Garden Grove, California, United States
Pfizer Investigational Site
Glendale, California, United States
Pfizer Investigational Site
Long Beach, California, United States
Pfizer Investigational Site
Long Beach, California, United States
Pfizer Investigational Site
National City, California, United States
Pfizer Investigational Site
Paramount, California, United States
Pfizer Investigational Site
Torrance, California, United States
...and 27 more locations
Time frame: 12 weeks
Change from baseline in Scale for Assessment of Negative Symptoms (SANS), modified
Time frame: 12 weeks
Change from baseline in Abbreviated Extrapyramidal Symptom Rating Scale
Time frame: 12 weeks
Change from baseline in Global Assessment of Functioning
Time frame: 12 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 15 weeks
Pharmacokinetic assays
Time frame: 12 weeks