The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.

Condition	Treatment or Intervention	Phase
Major Depressive Disorder	Drug: aripiprazole or placebo  Drug: escitalopram  Drug: paroxetine  Drug: venlafaxine  Drug: sertaline  Drug: bupropion	Phase III

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Men and women, 18-65 years old who have experienced single or recurrent, non-psychotic episodes of Major Depressive Disorder, with the current episode of minimally 8 weeks in duration.
• Treatment history of an inadequate response to at least one and no more than three adequate antidepressant trials.

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Alabama
      Local Institution, Birmingham,  Alabama,  United States
California
      Local Institution, San Diego,  California,  United States
      Local Institution, Los Alamitos,  California,  United States
Georgia
      Local Institution, Augusta,  Georgia,  United States
Illinois
      Local Institution, Hoffman Estates,  Illinois,  United States
Louisiana
      Local Institution, New Orleans,  Louisiana,  United States
Maryland
      Local Institution, Baltimore,  Maryland,  United States
Minnesota
      Local Institution, Minneapolis,  Minnesota,  United States
      Local Institution, St. Paul,  Minnesota,  United States
Nevada
      Local Institution, Las Vegas,  Nevada,  United States
New York
      Local Institution, Bronx,  New York,  United States
      Local Institution, Buffalo,  New York,  United States
North Carolina
      Local Institution, Charlotte,  North Carolina,  United States
Ohio
      Local Institution, Dayton,  Ohio,  United States
Oklahoma
      Local Institution, Oklahoma City,  Oklahoma,  United States
Pennsylvania
      Local Institution, Philadelphia,  Pennsylvania,  United States
South Carolina
      Local Institution, Columbia,  South Carolina,  United States
Utah
      Local Institution, Salt Lake City,  Utah,  United States
Virginia
      Local Institution, Charlottesville,  Virginia,  United States

Study ID Numbers:  CN138-165
Record last reviewed:  March 2005
Last Updated:  March 9, 2005
Record first received:  March 9, 2005
ClinicalTrials.gov Identifier:  NCT00105196
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08