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ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Depression Bipolar
Sex
Females and Males
Age
18-65 years
Inclusion Criteria
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- Men and women 18 to 65 years of age, inclusive.
- Diagnosis of Bipolar Disorder and must be experiencing a depressive episode.
Exclusion Criteria
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- 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
- Birmingham, Alabama
- Beverly Hills, California
- National City, California
- Stanford, California
- Farmington Hills, Connecticut
- Bradenton, Florida
- Jacksonville, Florida
- Orlando, Florida
- West Palm Beach, Florida
- Smyrna, Georgia
- Honolulu, Hawaii
- Terre Haute, Indiana
- Florence, Kentucky
- New Orleans, Louisiana
- Rockville, Maryland
- Boston, Massachusetts
- Farmington Hills, Michigan
- St Charles, Missouri
- Clementon, New Jersey
- Moorestown, New Jersey
- Bronx, New York
- Lawrence, New York
- New York, New York
- New York, New York
- Staten Island, New York
- Winston-Salem, North Carolina
- Cincinnati, Ohio
- Dayton, Ohio
- Lyndhurst, Ohio
- Oklahoma City, Oklahoma
- Tulsa, Oklahoma
- Portland, Oregon
- Philadelphia, Pennsylvania
- Charleston, South Carolina
- Austin, Texas
- Dallas, Texas
- Salt Lake City, Utah
- Bellevue, Washington
- Seattle, Washington
- 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 | 380 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | October 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |