Study Evaluating Bifeprunox in Bipolar Depression

This study has been completed.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00245973
First received: October 27, 2005
Last updated: December 3, 2007
Last verified: December 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 380
Study Start Date: June 2005
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245973

  Hide Study Locations
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, 73103
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00245973     History of Changes
Other Study ID Numbers: 3168A2-307
Study First Received: October 27, 2005
Last Updated: December 3, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 29, 2014