Study Evaluating Bifeprunox in Bipolar Depression

NCT00245973

Last updated date
Study Location
Birmingham, Alabama, 35216, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depression Bipolar
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men and women 18 to 65 years of age, inclusive.

- Diagnosis of Bipolar Disorder and must be experiencing a depressive episode.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Depression BipolarStudy Evaluating Bifeprunox in Bipolar Depression
NCT00245973
  1. Birmingham, Alabama
  2. Beverly Hills, California
  3. National City, California
  4. Stanford, California
  5. Farmington Hills, Connecticut
  6. Bradenton, Florida
  7. Jacksonville, Florida
  8. Orlando, Florida
  9. West Palm Beach, Florida
  10. Smyrna, Georgia
  11. Honolulu, Hawaii
  12. Terre Haute, Indiana
  13. Florence, Kentucky
  14. New Orleans, Louisiana
  15. Rockville, Maryland
  16. Boston, Massachusetts
  17. Farmington Hills, Michigan
  18. St Charles, Missouri
  19. Clementon, New Jersey
  20. Moorestown, New Jersey
  21. Bronx, New York
  22. Lawrence, New York
  23. New York, New York
  24. New York, New York
  25. Staten Island, New York
  26. Winston-Salem, North Carolina
  27. Cincinnati, Ohio
  28. Dayton, Ohio
  29. Lyndhurst, Ohio
  30. Oklahoma City, Oklahoma
  31. Tulsa, Oklahoma
  32. Portland, Oregon
  33. Philadelphia, Pennsylvania
  34. Charleston, South Carolina
  35. Austin, Texas
  36. Dallas, Texas
  37. Salt Lake City, Utah
  38. Bellevue, Washington
  39. Seattle, Washington
  40. Brown Deer, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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, MDWyeth 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