Clinical Trial: Study Evaluating Bifeprunox in Bipolar Depression

This study is currently recruiting patients.
Verified by Wyeth August 2005

Sponsors and Collaborators: Wyeth
Solvay Pharmaceuticals
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00134459

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.
Condition Intervention Phase
Depression Bipolar
 Drug: Bifeprunox
Phase III

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients with Bipolar Disorder

Further Study Details: 
Primary Outcomes: 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 Outcomes: using the change from baseline to endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as the primary efficacy endpoint.
Expected Total Enrollment:  380

Study start: June 2005

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Diagnosis of Bipolar Disorder
  • Experiencing a depressive episode

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00134459

Trial Manager       clinicaltrialinfo@wyeth.com

Alabama
      Birmingham,  Alabama,  35216,  United States; Recruiting
  see Central Contact 

California
      National City,  California,  91950,  United States; Recruiting
  see Central Contact 

      Stanford,  California,  94305,  United States; Not yet recruiting
  see Central Contact 

      Beverly Hills,  California,  90210,  United States; Recruiting
  see Central Contact 

Connecticut
      Farmington Hills,  Connecticut,  06030,  United States; Not yet recruiting
  see Central Contact 

Florida
      Bradenton,  Florida,  34208,  United States; Recruiting
  see Central Contact 

      Jacksonville,  Florida,  32216,  United States; Recruiting
  see Central Contact 

      West Palm Beach,  Florida,  33407,  United States; Recruiting
  see Central Contact 

      Orlando,  Florida,  32806,  United States; Recruiting
  see Central Contact 

Georgia
      Smyrna,  Georgia,  30080,  United States; Recruiting
  see Central Contact 

Hawaii
      Honolulu,  Hawaii,  96826,  United States; Recruiting
  see Central Contact 

Indiana
      Terre Haute,  Indiana,  47802,  United States; Recruiting
  see Central Contact 

Kentucky
      Florence,  Kentucky,  41042,  United States; Recruiting
  see Central Contact 

Louisiana
      New Orleans,  Louisiana,  70115,  United States; Recruiting
  see Central Contact 

Maryland
      Rockville,  Maryland,  20852,  United States; Recruiting
  see Central Contact 

Massachusetts
      Boston,  Massachusetts,  02114,  United States; Not yet recruiting
  see Central Contact 

Michigan
      Farmington Hills,  Michigan,  48336,  United States; Recruiting
  see Central Contact 

Missouri
      St. Charles,  Missouri,  63301,  United States; Recruiting
  see Central Contact 

New Jersey
      Clementon,  New Jersey,  08021,  United States; Recruiting
  see Central Contact 

      Moorestown,  New Jersey,  08057,  United States; Recruiting
  see Central Contact 

New York
      Bronx,  New York,  10467,  United States; Not yet recruiting
  see Central Contact 

      Lawrence,  New York,  11559,  United States; Recruiting
  see Central Contact 

      Staten Island,  New York,  10305,  United States; Recruiting
  see Central Contact 

      New York,  New York,  10024,  United States; Recruiting
  see Central Contact 

      New York,  New York,  10021,  United States; Recruiting
  see Central Contact 

North Carolina
      Winston Salem,  North Carolina,  27103,  United States; Recruiting
  see Central Contact 

Ohio
      Cincinnati,  Ohio,  45242,  United States; Recruiting
  see Central Contact 

      Dayton,  Ohio,  45408,  United States; Recruiting
  see Central Contact 

      Lyndhurst,  Ohio,  44124,  United States; Recruiting
  see Central Contact 

Oklahoma
      Oklahoma City,  Oklahoma,  United States; Recruiting
  see Central Contact 

      Tulsa,  Oklahoma,  74135,  United States; Recruiting
  see Central Contact 

Oregon
      Portland,  Oregon,  97210,  United States; Recruiting
  see Central Contact 

Pennsylvania
      Philadelphia,  Pennsylvania,  19149,  United States; Recruiting
  see Central Contact 

South Carolina
      Charleston,  South Carolina,  29407,  United States; Recruiting
  see Central Contact 

Texas
      Austin,  Texas,  78756,  United States; Recruiting
  see Central Contact 

      Austin,  Texas,  78756,  United States; Recruiting
  see Central Contact 

      Dallas,  Texas,  75390,  United States; Not yet recruiting
  see Central Contact 

Utah
      Salt Lake City,  Utah,  84107,  United States; Recruiting
  see Central Contact 

Washington
      Bellevue,  Washington,  98004,  United States; Recruiting
  see Central Contact 

      Seattle,  Washington,  98104,  United States; Recruiting
  see Central Contact 

Wisconsin
      Brown Deer,  Wisconsin,  53223,  United States; Recruiting
  see Central Contact 

Study chairs or principal investigators

Medical Monitor, MD,  Study Director,  Wyeth Research   

More Information

Study ID Numbers:  3168A2-304, 3168A2-307
Last Updated:  August 26, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00134459
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30



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