A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder

NCT ID: NCT00095745

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1002 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-11-30

Brief Summary

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This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antidepressant + Aripiprazole

Group Type NO_INTERVENTION

Antidepressant + Aripiprazole

Intervention Type DRUG

Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-30mg Aripiprazole, once daily, 52-weeks.

Interventions

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Antidepressant + Aripiprazole

Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-30mg Aripiprazole, once daily, 52-weeks.

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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Inclusion Criteria

* Men and women, 18 years or older
* Experiencing Major Depressive Disorder with a duration of minimally 8 weeks.
* Treatment history of an inadequate response to at least one and no more than four antidepressants
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Mesa, Arizona, United States

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Peoria, Arizona, United States

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Beverly Hills, California, United States

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Burbank, California, United States

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Encino, California, United States

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Garden Grove, California, United States

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National City, California, United States

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Orange, California, United States

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Pasadena, California, United States

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Riverside, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Farmington, Connecticut, United States

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

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Smyrna, Georgia, United States

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Chicago, Illinois, United States

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Edwardsville, Illinois, United States

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Oakbrook Terrace, Illinois, United States

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Terre Haute, Indiana, United States

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Overland Park, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Rockville, Maryland, United States

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Springfield, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Okemos, Michigan, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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Chapel Hill, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Toledo, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Woodstock, Vermont, United States

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Arlington, Virginia, United States

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Charlottesville, Virginia, United States

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Herndon, Virginia, United States

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Richmond, Virginia, United States

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Bellevue, Washington, United States

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Seattle, Washington, United States

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Morgantown, West Virginia, United States

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Brown Deer, Wisconsin, United States

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Middleton, Wisconsin, United States

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Countries

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United States

References

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Clayton AH, Baker RA, Sheehan JJ, Cain ZJ, Forbes RA, Marler SV, Marcus R, Berman RM, Thase ME. Comparison of adjunctive use of aripiprazole with bupropion or selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors: analysis of patients beginning adjunctive treatment in a 52-week, open-label study. BMC Res Notes. 2014 Jul 18;7:459. doi: 10.1186/1756-0500-7-459.

Reference Type DERIVED
PMID: 25037144 (View on PubMed)

Other Identifiers

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CN138-164

Identifier Type: -

Identifier Source: org_study_id