NCT00134459

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
434

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_3

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
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

February 15, 2013

Status Verified

July 1, 2009

Enrollment Period

11 months

First QC Date

August 22, 2005

Last Update Submit

February 12, 2013

Conditions

Bipolar Disorder

Keywords

DepressionBipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Using the change from baseline to endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS), total score as the primary efficacy endpoint

Interventions

BifeprunoxDRUG
PlaceboDRUG

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of bipolar disorder
  • Experiencing a depressive episode

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, 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 DisorderDepression

Interventions

bifeprunox

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

June 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

February 15, 2013

Record last verified: 2009-07

Locations

US(40)