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Trial record 1 of 1 for:    NCT00245973
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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.
 
ClinicalTrials.gov Identifier: NCT00245973
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : December 5, 2007
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE October 27, 2005
First Posted Date  ICMJE October 28, 2005
Last Update Posted Date December 5, 2007
Study Start Date  ICMJE June 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2006)
  • Secondary measurement scales will be used:
  • Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2005)
  • Secondary measurement scales will be used:
  • - Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2006)
  • Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
  • Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8
  • Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
  • Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
  • Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2005)
  • - Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
  • - Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8
  • - Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
  • - Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
  • - Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8.
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 Depression Bipolar
Intervention  ICMJE Drug: Bifeprunox
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
Enrollment  ICMJE
 (submitted: October 27, 2005)
380
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
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 NCT00245973
Other Study ID Numbers  ICMJE 3168A2-307
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
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 December 2007

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