Study Evaluating Bifeprunox in Bipolar Depression

Phase 3

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00134459
• 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

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-08-22
• Study First Posted: 2005-08-24
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2009-07
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 434

Inclusion Criteria

• Diagnosis of bipolar disorder
• Experiencing a depressive episode

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The objective of this study is to investigate if 8 weeks of treatment with flexible doses of bifeprunox (20 to 40 mg/day) is superior to treatment with placebo in depressed outpatients with bipolar disorder.

Secondary Outcome Measures

Name	Time	Method
Using the change from baseline to endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS), total score as the primary efficacy endpoint