Major Depressive Disorder Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 1002 |
| Est. completion date | November 2007 |
| Est. primary completion date | November 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution | Albuquerque | New Mexico |
| United States | Local Institution | Arlington | Virginia |
| United States | Local Institution | Atlanta | Georgia |
| United States | Local Institution | Austin | Texas |
| United States | Local Institution | Bellevue | Washington |
| United States | Local Institution | Beverly Hills | California |
| United States | Local Institution | Brooklyn | New York |
| United States | Local Institution | Brown Deer | Wisconsin |
| United States | Local Institution | Burbank | California |
| United States | Local Institution | Chapel Hill | North Carolina |
| United States | Local Institution | Charleston | South Carolina |
| United States | Local Institution | Charlottesville | Virginia |
| United States | Local Institution | Chicago | Illinois |
| United States | Local Institution | Cincinnati | Ohio |
| United States | Local Institution | Dallas | Texas |
| United States | Local Institution | Denver | Colorado |
| United States | Local Institution | East Providence | Rhode Island |
| United States | Local Institution | Edwardsville | Illinois |
| United States | Local Institution | Encino | California |
| United States | Local Institution | Farmington | Connecticut |
| United States | Local Institution | Farmington Hills | Michigan |
| United States | Local Institution | Gainesville | Florida |
| United States | Local Institution | Garden Grove | California |
| United States | Local Institution | Herndon | Virginia |
| United States | Local Institution | Houston | Texas |
| United States | Local Institution | Jacksonville | Florida |
| United States | Local Institution | Lexington | Kentucky |
| United States | Local Institution | Memphis | Tennessee |
| United States | Local Institution | Mesa | Arizona |
| United States | Local Institution | Middleton | Wisconsin |
| United States | Local Institution | Morgantown | West Virginia |
| United States | Local Institution | National City | California |
| United States | Local Institution | New York | New York |
| United States | Local Institution | Oakbrook Terrace | Illinois |
| United States | Local Institution | Okemos | Michigan |
| United States | Local Institution | Orange | California |
| United States | Local Institution | Orlando | Florida |
| United States | Local Institution | Overland Park | Kansas |
| United States | Local Institution | Pasadena | California |
| United States | Local Institution | Peoria | Arizona |
| United States | Local Institution | Philadelphia | Pennsylvania |
| United States | Local Institution | Pittsburgh | Pennsylvania |
| United States | Local Institution | Portland | Oregon |
| United States | Local Institution | Raleigh | North Carolina |
| United States | Local Institution | Richmond | Virginia |
| United States | Local Institution | Riverside | California |
| United States | Local Institution | Rockville | Maryland |
| United States | Local Institution | Salt Lake City | Utah |
| United States | Local Institution | San Diego | California |
| United States | Local Institution | Seattle | Washington |
| United States | Local Institution | Smyrna | Georgia |
| United States | Local Institution | Springfield | Massachusetts |
| United States | Local Institution | Staten Island | New York |
| United States | Local Institution | Terre Haute | Indiana |
| United States | Local Institution | Toledo | Ohio |
| United States | Local Institution | Washington | District of Columbia |
| United States | Local Institution | Wichita | Kansas |
| United States | Local Institution | Woodstock | Vermont |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka America Pharmaceutical |
United States,
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|---|---|---|---|---|
| Primary | Safety assessments | throughout the study | Yes |
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