A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder
A Multicenter, Long-Term, Open-label, Study to Assess the Safety and Tolerability of Aripiprazole as an Adjunctive Therapy in the Treatment of Outpatients With Major Depressive Disorder
1 other identifier
interventional
1,002
1 country
58
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
Started Sep 2004
Longer than P75 for phase_3 major-depressive-disorder
58 active sites
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
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 9, 2004
CompletedFirst Posted
Study publicly available on registry
November 9, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedNovember 8, 2013
April 1, 2011
3.2 years
November 9, 2004
November 7, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Safety assessments
throughout the study
Study Arms (1)
Antidepressant + Aripiprazole
NO INTERVENTIONInterventions
Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-30mg Aripiprazole, once daily, 52-weeks.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Local Institution
Mesa, Arizona, United States
Local Institution
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
Local Institution
Middleton, Wisconsin, United States
Related Publications (1)
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.
PMID: 25037144DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 9, 2004
First Posted
November 9, 2004
Study Start
September 1, 2004
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
November 8, 2013
Record last verified: 2011-04