Farmington Hills, Connecticut 06030

  • Bipolar Disorder


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.


Inclusion Criteria: - Diagnosis of bipolar disorder - Experiencing a depressive episode

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

Study Evaluating Bifeprunox in Bipolar Depression

Official Title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients With Bipolar Disorder

Overall Status:


Study Phase:

Phase 3



Minimum Age:

18 Years

Maximum Age:

65 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wyeth is now a wholly owned subsidiary of Pfizer

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Medical Monitor, MD
Study Director
Wyeth is now a wholly owned subsidiary of Pfizer

Study Dates

Start Date:June 2005
Completion Date:May 2006
Completion Type:Actual
Primary Completion Date:May 2006
Primary Completion Type:Actual
Verification Date:July 2009
Last Changed Date:February 12, 2013
First Received Date:August 22, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Using the change from baseline to endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS), total score as the primary efficacy endpoint
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Wyeth is now a wholly owned subsidiary of Pfizer
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Solvay Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: April 03, 2020

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