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Objective: Determine the efficacy and tolerability of olanzapine/fluoxetine combination (OFC) for treatment of acute bipolar I depression compared with lamotrigine.

Method: The 7-week, acute phase of a randomized, double-blind study compared OFC (6/25, 6/50, 12/25, or 12/50 mg/day; N= 205) with lamotrigine ([LMG] titrated to 200 mg/day; N= 205) in patients with DSM-IV–diagnosed bipolar I disorder, depressed. The study was conducted from November 2003 to August 2004.

Results: Completion rates were similar between treatments (OFC, 66.8% vs. LMG, 65.4%; p=. 835). OFC-treated patients had significantly greater improvement than lamotrigine-treated patients in change from baseline across the 7-week treatment period on the Clinical Global Impressions-Severity of Illness scale (primary outcome)(p=. 002, effect size= 0.26), Montgomery-Asberg Depression Rating Scale (MADRS)(p=. 002, effect size= 0.24 …