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: NCT00245973
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : December 5, 2007
Solvay Pharmaceuticals
Information provided by:
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
Depression Bipolar Drug: Bifeprunox Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 380 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 Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Secondary measurement scales will be used:
  2. Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8

Secondary Outcome Measures :
  1. Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
  2. Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8
  3. Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
  4. Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
  5. Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Men and women 18 to 65 years of age, inclusive.
  • Diagnosis of Bipolar Disorder and must be experiencing a depressive episode.

Exclusion Criteria:

  • This is a follow on study to protocol 3168A2-304. Only subjects who have participated in the previous study are eligible.

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): NCT00245973

  Hide Study Locations
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, 73103
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
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00245973     History of Changes
Other Study ID Numbers: 3168A2-307
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders