Study Evaluating Bifeprunox in Bipolar Depression

February 12, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

434

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
    • California
      • Beverly Hills, California, United States, 90210
      • National City, California, United States, 91950
      • Stanford, California, United States, 94305
    • Connecticut
      • Farmington Hills, Connecticut, United States, 06030
    • Florida
      • Bradenton, Florida, United States, 34208
      • Jacksonville, Florida, United States, 32216
      • Orlando, Florida, United States, 32806
      • West Palm Beach, Florida, United States, 33407
    • Georgia
      • Smyrna, Georgia, United States, 30080
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
    • Indiana
      • Terre Haute, Indiana, United States, 47802
    • Kentucky
      • Florence, Kentucky, United States, 41042
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
    • Maryland
      • Rockville, Maryland, United States, 20852
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
    • Missouri
      • St Charles, Missouri, United States, 63301
    • New Jersey
      • Clementon, New Jersey, United States, 08021
      • Moorestown, New Jersey, United States, 08057
    • New York
      • Bronx, New York, United States, 10467
      • Lawrence, New York, United States, 11559
      • New York, New York, United States, 10021
      • New York, New York, United States, 10024
      • Staten Island, New York, United States, 10305
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Dayton, Ohio, United States, 45408
      • Lyndhurst, Ohio, United States, 44124
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States, 74135
    • Oregon
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19149
    • South Carolina
      • Charleston, South Carolina, United States, 29407
    • Texas
      • Austin, Texas, United States, 78756
      • Dallas, Texas, United States, 75390
    • Utah
      • Salt Lake City, Utah, United States, 84107
    • Washington
      • Bellevue, Washington, United States, 98004
      • Seattle, Washington, United States, 98104
    • Wisconsin
      • Brown Deer, Wisconsin, United States, 53223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of bipolar disorder
  • Experiencing a depressive episode

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 22, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3168A2-304
  • B3101016 (Other Identifier: Pfizer)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Disorder

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe