Study Evaluating Bifeprunox in Bipolar Depression
Phase 3
Completed
- Conditions
- Depression Bipolar
- Registration Number
- NCT00245973
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
The purpose of the study is to investigate whether eight weeks of treatment with flexible doses of Bifeprunox is superior to treatment with placebo in depressed patients with bipolar disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
Inclusion Criteria
- Men and women 18 to 65 years of age, inclusive.
- Diagnosis of Bipolar Disorder and must be experiencing a depressive episode.
Exclusion Criteria
- This is a follow on study to protocol 3168A2-304. Only subjects who have participated in the previous study are eligible.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Secondary measurement scales will be used: Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8
- Secondary Outcome Measures
Name Time Method Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8 Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8