Study Evaluating Bifeprunox in Bipolar Depression

December 3, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients With Bipolar Disorder

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.

Study Overview

Status

Completed

Conditions

Depression Bipolar

Intervention / Treatment

Drug: Bifeprunox

Study Type

Interventional

Enrollment

380

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35216
- California
  - Beverly Hills, California, United States, 90210
  - National City, California, United States, 91950
  - Stanford, California, United States, 94305
- Connecticut
  - Farmington Hills, Connecticut, United States, 06030
- Florida
  - Bradenton, Florida, United States, 34208
  - Jacksonville, Florida, United States, 32216
  - Orlando, Florida, United States, 32806
  - West Palm Beach, Florida, United States, 33407
- Georgia
  - Smyrna, Georgia, United States, 30080
- Hawaii
  - Honolulu, Hawaii, United States, 96826
- Indiana
  - Terre Haute, Indiana, United States, 47802
- Kentucky
  - Florence, Kentucky, United States, 41042
- Louisiana
  - New Orleans, Louisiana, United States, 70115
- Maryland
  - Rockville, Maryland, United States, 20852
- Massachusetts
  - Boston, Massachusetts, United States, 02114
- Michigan
  - Farmington Hills, Michigan, United States, 48336
- Missouri
  - St Charles, Missouri, United States, 63301
- New Jersey
  - Clementon, New Jersey, United States, 08021
  - Moorestown, New Jersey, United States, 08057
- 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
- North Carolina
  - Winston-Salem, North Carolina, United States, 27103
- Ohio
  - Cincinnati, Ohio, United States, 45242
  - Dayton, Ohio, United States, 45408
  - Lyndhurst, Ohio, United States, 44124
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73103
  - Tulsa, Oklahoma, United States, 74135
- Oregon
  - Portland, Oregon, United States, 97210
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19149
- South Carolina
  - Charleston, South Carolina, United States, 29407
- Texas
  - Austin, Texas, United States, 78756
  - Dallas, Texas, United States, 75390
- Utah
  - Salt Lake City, Utah, United States, 84107
- Washington
  - Bellevue, Washington, United States, 98004
  - Seattle, Washington, United States, 98104
- Wisconsin
  - Brown Deer, Wisconsin, United States, 53223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Secondary measurement scales will be used:
Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8

Secondary Outcome Measures

Outcome Measure
Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8
Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

October 27, 2005

First Submitted That Met QC Criteria

October 27, 2005

First Posted (Estimate)

October 28, 2005

Study Record Updates

Last Update Posted (Estimate)

December 5, 2007

Last Update Submitted That Met QC Criteria

December 3, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

3168A2-307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.