NCT00245973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

40 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

December 5, 2007

Status Verified

December 1, 2007

First QC Date

October 27, 2005

Last Update Submit

December 3, 2007

Conditions

Depression Bipolar

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

Interventions

BifeprunoxDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 18 to 65 years of age, inclusive.
  • Diagnosis of Bipolar Disorder and must be experiencing a depressive episode.

You may not qualify if:

  • This is a follow on study to protocol 3168A2-304. Only subjects who have participated in the previous study are eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

Unknown Facility

Birmingham, Alabama, 35216, United States

Location

Unknown Facility

Beverly Hills, California, 90210, United States

Location

Unknown Facility

National City, California, 91950, United States

Location

Unknown Facility

Stanford, California, 94305, United States

Location

Unknown Facility

Farmington Hills, Connecticut, 06030, United States

Location

Unknown Facility

Bradenton, Florida, 34208, United States

Location

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

Orlando, Florida, 32806, United States

Location

Unknown Facility

West Palm Beach, Florida, 33407, United States

Location

Unknown Facility

Smyrna, Georgia, 30080, United States

Location

Unknown Facility

Honolulu, Hawaii, 96826, United States

Location

Unknown Facility

Terre Haute, Indiana, 47802, United States

Location

Unknown Facility

Florence, Kentucky, 41042, United States

Location

Unknown Facility

New Orleans, Louisiana, 70115, United States

Location

Unknown Facility

Rockville, Maryland, 20852, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Farmington Hills, Michigan, 48336, United States

Location

Unknown Facility

Saint Charles, Missouri, 63301, United States

Location

Unknown Facility

Clementon, New Jersey, 08021, United States

Location

Unknown Facility

Moorestown, New Jersey, 08057, United States

Location

Unknown Facility

Lawrence, New York, 11559, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

Unknown Facility

New York, New York, 10024, United States

Location

Unknown Facility

Staten Island, New York, 10305, United States

Location

Unknown Facility

The Bronx, New York, 10467, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Cincinnati, Ohio, 45242, United States

Location

Unknown Facility

Dayton, Ohio, 45408, United States

Location

Unknown Facility

Lyndhurst, Ohio, 44124, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73103, United States

Location

Unknown Facility

Tulsa, Oklahoma, 74135, United States

Location

Unknown Facility

Portland, Oregon, 97210, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19149, United States

Location

Unknown Facility

Charleston, South Carolina, 29407, United States

Location

Unknown Facility

Austin, Texas, 78756, United States

Location

Unknown Facility

Dallas, Texas, 75390, United States

Location

Unknown Facility

Salt Lake City, Utah, 84107, United States

Location

Unknown Facility

Bellevue, Washington, 98004, United States

Location

Unknown Facility

Seattle, Washington, 98104, United States

Location

Unknown Facility

Brown Deer, Wisconsin, 53223, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

bifeprunox

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 28, 2005

Study Start

June 1, 2005

Study Completion

October 1, 2007

Last Updated

December 5, 2007

Record last verified: 2007-12

Locations

US(40)