Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
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|ClinicalTrials.gov Identifier: NCT00396214|
Recruitment Status : Terminated (This trial discontinued on 2 May 2008 due to lack of enrolment)
First Posted : November 6, 2006
Last Update Posted : June 4, 2008
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Bifeprunox Drug: Quetiapine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 1 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 2 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
|Active Comparator: 3||
Fixed oral dose of quetiapine at 400 mg/day to be administered in divided doses (BID) utilizing a 5-day upward titration from 50 mg/day.
- Weight [ Time Frame: 8 weeks ]
- Change from baseline in Triglyceride [ Time Frame: 8 weeks ]
- Detorioration (composite definition using PANSS total score and CGI-I) [ Time Frame: 26 weeks ]
- Change from baseline in Weight, Triglyceride and Cardiovascular risk factors [ Time Frame: 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396214
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|Study Director:||Global Clinical Director Solvay||Solvay Pharmaceuticals|