Study Evaluating Bifeprunox in Bipolar Depression

NCT ID: NCT00245973

Last Updated: 2007-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-10-31

Brief Summary

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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

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Conditions

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Depression Bipolar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Bifeprunox

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Birmingham, Alabama, United States

Site Status

Beverly Hills, California, United States

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National City, California, United States

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Stanford, California, United States

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Farmington Hills, Connecticut, United States

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Bradenton, Florida, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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West Palm Beach, Florida, United States

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Smyrna, Georgia, United States

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Honolulu, Hawaii, United States

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Terre Haute, Indiana, United States

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Florence, Kentucky, United States

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New Orleans, Louisiana, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Saint Charles, Missouri, United States

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Clementon, New Jersey, United States

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Moorestown, New Jersey, United States

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Lawrence, New York, United States

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New York, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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The Bronx, New York, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Lyndhurst, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Salt Lake City, Utah, United States

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Bellevue, Washington, United States

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Seattle, Washington, United States

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Brown Deer, Wisconsin, United States

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Countries

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United States

Other Identifiers

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3168A2-307

Identifier Type: -

Identifier Source: org_study_id