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

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

Sponsors

Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborator: Otsuka America Pharmaceutical

Source Otsuka Pharmaceutical Development & Commercialization, Inc.
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.

Overall Status Completed
Start Date September 2004
Completion Date November 2007
Primary Completion Date November 2007
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety assessments throughout the study
Enrollment 1002
Condition
Intervention

Intervention type: Drug

Intervention name: Antidepressant + Aripiprazole

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

Arm group label: Antidepressant + Aripiprazole

Other name: Abilify

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Location
facility
Local Institution | Mesa, Arizona, United States
Local Institution | Peoria, Arizona, United States
Local Institution | Beverly Hills, California, United States
Local Institution | Burbank, California, United States
Local Institution | Encino, California, United States
Local Institution | Garden Grove, California, United States
Local Institution | National City, California, United States
Local Institution | Orange, California, United States
Local Institution | Pasadena, California, United States
Local Institution | Riverside, California, United States
Local Institution | San Diego, California, United States
Local Institution | Denver, Colorado, United States
Local Institution | Farmington, Connecticut, United States
Local Institution | Washington, District of Columbia, United States
Local Institution | Gainesville, Florida, United States
Local Institution | Jacksonville, Florida, United States
Local Institution | Orlando, Florida, United States
Local Institution | Atlanta, Georgia, United States
Local Institution | Smyrna, Georgia, United States
Local Institution | Chicago, Illinois, United States
Local Institution | Edwardsville, Illinois, United States
Local Institution | Oakbrook Terrace, Illinois, United States
Local Institution | Terre Haute, Indiana, United States
Local Institution | Overland Park, Kansas, United States
Local Institution | Wichita, Kansas, United States
Local Institution | Lexington, Kentucky, United States
Local Institution | Rockville, Maryland, United States
Local Institution | Springfield, Massachusetts, United States
Local Institution | Farmington Hills, Michigan, United States
Local Institution | Okemos, Michigan, United States
Local Institution | Albuquerque, New Mexico, United States
Local Institution | Brooklyn, New York, United States
Local Institution | New York, New York, United States
Local Institution | Staten Island, New York, United States
Local Institution | Chapel Hill, North Carolina, United States
Local Institution | Raleigh, North Carolina, United States
Local Institution | Cincinnati, Ohio, United States
Local Institution | Toledo, Ohio, United States
Local Institution | Portland, Oregon, United States
Local Institution | Philadelphia, Pennsylvania, United States
Local Institution | Pittsburgh, Pennsylvania, United States
Local Institution | East Providence, Rhode Island, United States
Local Institution | Charleston, South Carolina, United States
Local Institution | Memphis, Tennessee, United States
Local Institution | Austin, Texas, United States
Local Institution | Dallas, Texas, United States
Local Institution | Houston, Texas, United States
Local Institution | Salt Lake City, Utah, United States
Local Institution | Woodstock, Vermont, United States
Local Institution | Arlington, Virginia, United States
Local Institution | Charlottesville, Virginia, United States
Local Institution | Herndon, Virginia, United States
Local Institution | Richmond, Virginia, United States
Local Institution | Bellevue, Washington, United States
Local Institution | Seattle, Washington, United States
Local Institution | Morgantown, West Virginia, United States
Local Institution | Brown Deer, Wisconsin, United States
Local Institution | Middleton, Wisconsin, United States
Location Countries

United States

Verification Date

April 2011

Responsible Party

Name title: Study Director

Organization: Bristol-Myers Squibb

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Antidepressant + Aripiprazole

Arm group type: No Intervention

Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov