Schizophrenia
Conditions
Keywords
schizophrenia negative symptoms adjunctive
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.
Interventions
DRUGPF-03463275
30 mg Controlled Release tablet BID for 12 weeks
DRUGPlacebo
Placebo tablet BID
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Quality of Life Scale (QLS) | 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 |
| Change from baseline in Abbreviated Extrapyramidal Symptom Rating Scale | 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 |
Countries
United States
Outcome results
None listed