Not Signed In -
Depression |
Depression/depressive Disorders |
Clinical Trial: Study Evaluating Bifeprunox in Bipolar Depression
This study is currently recruiting patients.
Verified by Wyeth August 2005
|
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
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
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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