this systematic review assessed the safety and efficacy of olanzapine-fluoxetine combination (OFC) for treatment of bipolar depression, specifically in studies of 8 to 12 weeks duration in adults (primary objective) and adolescents (secondary objective).
Materials and methods:
trials were identified using MEDLINE, EMBASE, Cochrane Library, Web of Knowledge, LILACS, WHOLIS, NEURO, Latindex, and DIALNET (2000 – July 2014). English and Spanish free-text and MeSH terms were used. Searches were supplemented with identified trials (Clinical Trials.gov) and congress abstracts. Evidence from randomized controlled trials (RCTs), nonrandomized trials, and meta-analyses were considered.
nine publications reporting 5 RCTs (6 publications), 1 nonrandomized trial, and 2 metaanalyses were included. One RCT was conducted in adolescents and one RCT was conducted in a Latin American population. Studies enrolled from 34 to 833 participants, were conducted for 7 to 8 weeks and up to 6 months, and varied in methodological quality and reporting. The efficacy of OFC (depression rating scales, response and remission rates) was greater compared with olanzapine monotherapy, lamotrigine monotherapy, and placebo. OFC was well tolerated in adults and adolescents. However, there was a greater frequency of weight gain, somnolence, nausea, diarrhea, and elevated metabolic parameters in participants receiving OFC versus active comparators or placebo.
this systematic review presents findings that OFC is effective and generally well tolerated for acute treatment of bipolar depression in adults and adolescents. Existing evidence suggests that the efficacy and safety profile of OFC in patients from Latin America is not different to Caucasian populations.
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