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How effective and safe is aripiprazole as an adjunctive treatment for major depressive disorder (MDD) in people who have failed to respond to one or more antidepressants?
381 adult outpatients (aged 18–65 years) with a DSM-IV diagnosis of MDD, who had inadequate response to an 8–week single blind antidepressant trial, and had previously experienced inadequate response to between one and three antidepressants (assessed using the Antidepressant Treatment Response Questionnaire). See online notes for details.
36 sites in the USA; September 2004 to December 2006.
Adjunctive aripiprazole (starting dose 5 mg/day, which could be adjusted to a maximum of 20 mg/day as tolerated by week 4) or placebo for 6 weeks. Type of antidepressant or dosage was not changed during this period.
Change in symptoms from baseline (Montgomery-Åsberg Depression Rating Scale (MADRS)); adverse events.
85% completed treatment (97% analysed for efficacy using last observation …
Source of funding: Bristol-Myers Squibb, Otsuka Pharmaceutical Co, Ltd.
Additional notes are published online only at http://ebmh.bmj.com/content/vol11/issue4
Competing interests:AC has received reimbursement for attending conferences from Eli Lilly and Co; a fee for speaking and/or fees for consulting from Eli Lilly and Co, UCB Pharma, Cyberonics, Organon and Merck; and funds for research from GlaxoSmithKline.
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