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

Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Antidepressant + Aripiprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety assessments

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: September 2004
Last updated: November 7, 2013

Page last updated: August 20, 2015

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