Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
- Registration Number
- NCT00396214
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 83
Inclusion Criteria
- Diagnosis of Schizophrenia
- 18-65 years
- No hospitalization for an exacerbation of schizophrenia within two months prior to screening and during the screening period
Exclusion Criteria
- Subjects who are acutely psychotic or subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
- At significant risk of suicide, and the potential for violent behavior (likely to harm themselves or others) based on history
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Bifeprunox - 1 Bifeprunox - 3 Quetiapine -
- Primary Outcome Measures
Name Time Method Weight 8 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in Triglyceride 8 weeks Detorioration (composite definition using PANSS total score and CGI-I) 26 weeks Change from baseline in Weight, Triglyceride and Cardiovascular risk factors 52 weeks
Trial Locations
- Locations (151)
Site 313
🇺🇸Anaheim, California, United States
Site 333
🇺🇸Anaheim, California, United States
Site 323
🇺🇸Cerritos, California, United States
Site 374
🇺🇸Costa Mesa, California, United States
Site 326
🇺🇸Culver City, California, United States
Site 300
🇺🇸Glendale, California, United States
Site 343
🇺🇸Long Beach, California, United States
Site 356
🇺🇸Los Angeles, California, United States
Site 367
🇺🇸Los Angeles, California, United States
Site 322
🇺🇸Oceanside, California, United States
Scroll for more (141 remaining)Site 313🇺🇸Anaheim, California, United States