Switch Study of Existing Atypical Antipsychotics to Bifeprunox
Phase 3
Completed
- Conditions
- Schizophrenia and Schizoaffective Disorder
- Interventions
- Registration Number
- NCT00347425
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 286
Inclusion Criteria
- Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated
Exclusion Criteria
- Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Aripiprazole - A Olanzapine - A Risperidone - A Quetiapine - B Aripiprazole - B Olanzapine - B Risperidone - B Ziprasidone - A Ziprasidone - B Quetiapine -
- Primary Outcome Measures
Name Time Method Successful switch defined as those who complete the 4 weeks core study with no worsening of 2 successive post baseline assessments on the CGIS, exacerbation of EPS, or cardiovascular risk factors (body weight and fasting triglycerides) from baseline. 4 weeks
- Secondary Outcome Measures
Name Time Method Adverse events 26 weeks
Trial Locations
- Locations (122)
Site 148
🇺🇸Birmingham, Alabama, United States
Site 194
🇺🇸Little Rock, Arkansas, United States
Site 178
🇺🇸Anaheim, California, United States
Site 167
🇺🇸Cerritos, California, United States
Site 189
🇺🇸Cerritos, California, United States
Site 183
🇺🇸Culver City, California, United States
Site 140
🇺🇸Garden Grove, California, United States
Site 162
🇺🇸La Palma, California, United States
Site 190
🇺🇸Long Beach, California, United States
Site 173
🇺🇸Oceanside, California, United States
Scroll for more (112 remaining)Site 148🇺🇸Birmingham, Alabama, United States