Expired Study
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West Palm Beach, Florida 33407


Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

3168A2-304


NCT ID:

NCT00134459


Secondary ID:

B3101016


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:

Completed


Study Phase:

Phase 3


Genders:

Both


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:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

434


Enrollment Type:

Actual


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
Name:Bifeprunox
Intervention Type:Drug
Name:Placebo

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: ClinicalTrials.gov

Date Processed: January 21, 2020

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