NCT00139919CompletedPhase 2
A Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study of the Safety and Tolerability of Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Either Schizophrenia or Bipolar Disorder With an Optional Open-Label 26-Week Extension Study
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Solvay Pharmaceuticals
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Study Sites (1)
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