Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00134459
Previous Study | Return to List | Next Study

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.
 
ClinicalTrials.gov Identifier: NCT00134459
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : February 15, 2013
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE August 22, 2005
First Posted Date  ICMJE August 24, 2005
Last Update Posted Date February 15, 2013
Study Start Date  ICMJE June 2005
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2005)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2005)
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,
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2005)
Using the change from baseline to endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS), total score as the primary efficacy endpoint
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2005)
using the change from baseline to endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as the primary efficacy endpoint.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Bifeprunox in Bipolar Depression
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients With Bipolar Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Drug: Bifeprunox
  • Drug: Placebo
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2013)
434
Original Enrollment  ICMJE
 (submitted: August 22, 2005)
380
Actual Study Completion Date  ICMJE May 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of bipolar disorder
  • Experiencing a depressive episode
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00134459
Other Study ID Numbers  ICMJE 3168A2-304
B3101016 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Solvay Pharmaceuticals
Investigators  ICMJE
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP