Study Evaluating Bifeprunox in Bipolar Depression
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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 |
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Recruitment Status :
Completed
First Posted : August 24, 2005
Last Update Posted : February 15, 2013
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Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bipolar Disorder | Drug: Bifeprunox Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 434 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients With Bipolar Disorder |
| Study Start Date : | June 2005 |
| Actual Primary Completion Date : | May 2006 |
| Actual Study Completion Date : | May 2006 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Bipolar Disorder
Primary Outcome Measures :
- 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 Outcome Measures :
- Using the change from baseline to endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS), total score as the primary efficacy endpoint
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of bipolar disorder
- Experiencing a depressive episode
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134459
Locations
| United States, Alabama | |
| Birmingham, Alabama, United States, 35216 | |
| United States, California | |
| Beverly Hills, California, United States, 90210 | |
| National City, California, United States, 91950 | |
| Stanford, California, United States, 94305 | |
| United States, Connecticut | |
| Farmington Hills, Connecticut, United States, 06030 | |
| United States, Florida | |
| Bradenton, Florida, United States, 34208 | |
| Jacksonville, Florida, United States, 32216 | |
| Orlando, Florida, United States, 32806 | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Smyrna, Georgia, United States, 30080 | |
| United States, Hawaii | |
| Honolulu, Hawaii, United States, 96826 | |
| United States, Indiana | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Kentucky | |
| Florence, Kentucky, United States, 41042 | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States, 70115 | |
| United States, Maryland | |
| Rockville, Maryland, United States, 20852 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Farmington Hills, Michigan, United States, 48336 | |
| United States, Missouri | |
| St Charles, Missouri, United States, 63301 | |
| United States, New Jersey | |
| Clementon, New Jersey, United States, 08021 | |
| Moorestown, New Jersey, United States, 08057 | |
| United States, New York | |
| Bronx, New York, United States, 10467 | |
| Lawrence, New York, United States, 11559 | |
| New York, New York, United States, 10021 | |
| New York, New York, United States, 10024 | |
| Staten Island, New York, United States, 10305 | |
| United States, North Carolina | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45242 | |
| Dayton, Ohio, United States, 45408 | |
| Lyndhurst, Ohio, United States, 44124 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| Tulsa, Oklahoma, United States, 74135 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19149 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29407 | |
| United States, Texas | |
| Austin, Texas, United States, 78756 | |
| Dallas, Texas, United States, 75390 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Washington | |
| Bellevue, Washington, United States, 98004 | |
| Seattle, Washington, United States, 98104 | |
| United States, Wisconsin | |
| Brown Deer, Wisconsin, United States, 53223 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Solvay Pharmaceuticals
Investigators
| Study Director: | Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer |
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00134459 |
| Other Study ID Numbers: |
3168A2-304 B3101016 ( Other Identifier: Pfizer ) |
| First Posted: | August 24, 2005 Key Record Dates |
| Last Update Posted: | February 15, 2013 |
| Last Verified: | July 2009 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
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Depression Bipolar Disorder |
Additional relevant MeSH terms:
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Depression Bipolar Disorder Behavioral Symptoms Mental Disorders Bipolar and Related Disorders |