Back to resultsA Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Antidepressant + Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
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
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Antidepressant + Aripiprazole
Arm Description
Outcomes
Primary Outcome Measures
Safety assessments
Secondary Outcome Measures
Full Information
NCT ID
NCT00095745
First Posted
November 9, 2004
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00095745
Brief Title
A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1002 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antidepressant + Aripiprazole
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Antidepressant + Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-30mg Aripiprazole, once daily, 52-weeks.
Primary Outcome Measure Information:
Title
Safety assessments
Time Frame
throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Mesa
State/Province
Arizona
Country
United States
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City
Peoria
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Arizona
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United States
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Beverly Hills
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California
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United States
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Burbank
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California
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United States
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Encino
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California
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United States
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Garden Grove
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California
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United States
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National City
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California
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United States
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Orange
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California
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United States
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Pasadena
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California
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United States
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Riverside
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California
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United States
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San Diego
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United States
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Denver
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Colorado
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United States
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Farmington
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Connecticut
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United States
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Washington
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United States
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Gainesville
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United States
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Jacksonville
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United States
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Orlando
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United States
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Atlanta
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Georgia
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United States
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Smyrna
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Georgia
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United States
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Chicago
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Illinois
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United States
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Edwardsville
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Illinois
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United States
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Oakbrook Terrace
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Illinois
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United States
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Terre Haute
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Indiana
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United States
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Overland Park
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Wichita
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Lexington
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United States
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Rockville
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Springfield
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Farmington Hills
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United States
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Okemos
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United States
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Albuquerque
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New Mexico
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United States
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Brooklyn
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New York
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United States
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Staten Island
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Chapel Hill
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United States
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Raleigh
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United States
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Cincinnati
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United States
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Toledo
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United States
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Portland
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Oregon
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United States
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Philadelphia
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United States
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Pittsburgh
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United States
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East Providence
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Rhode Island
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United States
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Charleston
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South Carolina
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United States
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Memphis
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Tennessee
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United States
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Austin
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United States
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Dallas
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United States
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Houston
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United States
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Salt Lake City
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Utah
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United States
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Woodstock
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Vermont
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Arlington
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United States
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Charlottesville
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Virginia
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United States
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Herndon
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Virginia
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United States
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Richmond
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Bellevue
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United States
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Seattle
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United States
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Morgantown
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West Virginia
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United States
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Brown Deer
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Wisconsin
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United States
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Middleton
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Wisconsin
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United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25037144
Citation
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.
Results Reference
derived
Learn more about this trial
A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder
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