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Robert M Berman, MD
Bristol-Myers Squibb Co., 5 Research Parkway, Wallingford, CT 06492, USA; Robert.Berman@bms.com
How effective and safe is aripiprazole when added to antidepressants in people with major depressive disorder and a history of incomplete response?
362 adults with major depressive disorder (DSM-IV-TR) whose current episode had failed to show complete response to an 8-week trial of standard antidepressant plus adjunctive placebo. Incomplete response was defined as <50% reduction in 17-item Hamilton Rating Scale for Depression (HAM-D17) total score, HAM-D17 score ⩾14, and a Clinical Global Impressions-Improvement scale score ⩾3. Participants enrolled in the 8-week trial had to have HAM-D17 total score ⩾18, and a history of inadequate response (<50% reduction in Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ)) to 1–3 adequate antidepressant treatments (>6 weeks using adequate dose as specified in the ATRQ) for their current depressive episode.
24 sites in the USA; June 2004 to April 2006.
Adjunctive aripiprazole (2–20 mg daily depending on antidepressant being …
Source of funding: Bristol-Myers Squibb Co and Otsuka Pharmaceutical Co, Ltd.
Competing interests: None declared.