NCT00094432

Brief Summary

The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
650

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2004

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, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

November 11, 2013

Status Verified

June 1, 2008

Enrollment Period

2.4 years

First QC Date

October 18, 2004

Last Update Submit

November 7, 2013

Conditions

Bipolar I Disorder

Keywords

depressed

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline to endpoint on the MADRS total score.

Secondary Outcomes (3)

  • Clinical Global Impression - Bipolar Version

  • Severity of illness score depression

  • Mean change from baseline to endpoint

Study Arms (2)

A1

ACTIVE COMPARATOR
Drug: Aripiprazole

A2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AripiprazoleDRUG

Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.

Also known as: Abilify
A1
PlaceboDRUG

Tablets, Oral, 0 mg, Once daily, 8 weeks.

A2

Eligibility Criteria

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

You may qualify if:

  • Men and women, ages 18-65
  • Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

Local Institution

Mesa, Arizona, United States

Location

Local Institution

La Mesa, California, United States

Location

Local Institution

La Palma, California, United States

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Local Institution

Long Beach, California, United States

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Local Institution

Redlands, California, United States

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San Diego, California, United States

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Local Institution

Sherman Oaks, California, United States

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Local Institution

Washington D.C., District of Columbia, United States

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Local Institution

Coral Springs, Florida, United States

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Local Institution

Jacksonville, Florida, United States

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Local Institution

St. Petersburg, Florida, United States

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Local Institution

Marietta, Georgia, United States

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Local Institution

Edwardsville, Illinois, United States

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Local Institution

Oak Brook, Illinois, United States

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Springfield, Illinois, United States

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Lafayette, Indiana, United States

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Newton, Kansas, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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St Louis, Missouri, United States

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Clementon, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Elmsford, New York, United States

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New York, New York, United States

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Raleigh, North Carolina, United States

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Dayton, Ohio, United States

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Local Institution

Media, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Columbia, South Carolina, United States

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DeSoto, Texas, United States

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Local Institution

Houston, Texas, United States

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Local Institution

Wichita Falls, Texas, United States

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Local Institution

Salt Lake City, Utah, United States

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Local Institution

Charlottesville, Virginia, United States

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Local Institution

Midlothian, Virginia, United States

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Local Institution

Bellevue, Washington, United States

Location

Local Institution

Charleston, West Virginia, United States

Location

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2004

First Posted

October 19, 2004

Study Start

June 1, 2004

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

November 11, 2013

Record last verified: 2008-06

Locations

US(40)