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Study Evaluating Bifeprunox in Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00134459
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : February 15, 2013
Solvay Pharmaceuticals
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Bifeprunox Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 434 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients With Bipolar Disorder
Study Start Date : June 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Primary Outcome Measures :
  1. 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 :
  1. Using the change from baseline to endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS), total score as the primary efficacy endpoint

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of bipolar disorder
  • Experiencing a depressive episode

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00134459

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United States, Alabama
Birmingham, Alabama, United States, 35216
United States, California
Beverly Hills, California, United States, 90210
National City, California, United States, 91950
Stanford, California, United States, 94305
United States, Connecticut
Farmington Hills, Connecticut, United States, 06030
United States, Florida
Bradenton, Florida, United States, 34208
Jacksonville, Florida, United States, 32216
Orlando, Florida, United States, 32806
West Palm Beach, Florida, United States, 33407
United States, Georgia
Smyrna, Georgia, United States, 30080
United States, Hawaii
Honolulu, Hawaii, United States, 96826
United States, Indiana
Terre Haute, Indiana, United States, 47802
United States, Kentucky
Florence, Kentucky, United States, 41042
United States, Louisiana
New Orleans, Louisiana, United States, 70115
United States, Maryland
Rockville, Maryland, United States, 20852
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Michigan
Farmington Hills, Michigan, United States, 48336
United States, Missouri
St Charles, Missouri, United States, 63301
United States, New Jersey
Clementon, New Jersey, United States, 08021
Moorestown, New Jersey, United States, 08057
United States, 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
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati, Ohio, United States, 45242
Dayton, Ohio, United States, 45408
Lyndhurst, Ohio, United States, 44124
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States, 74135
United States, Oregon
Portland, Oregon, United States, 97210
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19149
United States, South Carolina
Charleston, South Carolina, United States, 29407
United States, Texas
Austin, Texas, United States, 78756
Dallas, Texas, United States, 75390
United States, Utah
Salt Lake City, Utah, United States, 84107
United States, Washington
Bellevue, Washington, United States, 98004
Seattle, Washington, United States, 98104
United States, Wisconsin
Brown Deer, Wisconsin, United States, 53223
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Solvay Pharmaceuticals
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00134459    
Other Study ID Numbers: 3168A2-304
B3101016 ( Other Identifier: Pfizer )
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: July 2009
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Bipolar Disorder
Additional relevant MeSH terms:
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Bipolar Disorder
Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders