Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder
Phase 2
Completed
- Conditions
- Bipolar DisorderSchizophreniaSchizoaffective Disorder
- Registration Number
- NCT00139919
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
This study is to assess the tolerability of bifeprunox with the progressive elimination of titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an optional open-label 26-week extension study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Subjects with the current Diagnosis of Schizophrenia, Bipolar Type I Disorder according to DSM-IV TR criteria
- Age 18 to 55
- Body weight 100-250 lbs
- Be sufficiently stable to allow discontinuation of antipsychotic medication
Exclusion Criteria
- Acutely psychotic subjects
- Subjects that are acutely manic
- Subjects with a psych diagnosis other than Bipolar Type I Disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site 1
🇺🇸Orange, California, United States