• Daniel Ventura, Edward P Armstrong, Grant H Skrepnek, and M Haim Erder.
• Forest Research Institute, Jersey City, NJ 07311, USA. Daniel.Ventura@frx.com
• Curr Med Res Opin. 2007 Feb 1; 23 (2): 245250245-50.

ObjectiveThis trial was conducted to compare the efficacy and tolerability of a fixed dose of escitalopram 10 mg/day with sertraline optimally dosed within its recommended dose range (50-200 mg/day) for the treatment of major depressive disorder.MethodsIn this multicenter trial, depressed patients (DSM-IV defined; baseline Montgomery-Asberg Depression Rating Scale [MADRS] 22) aged 18-80 years were randomly assigned to 8 weeks of double-blind treatment with escitalopram (10 mg/day) or sertraline (50-200 mg/day) following a 1-week single-blind placebo lead-in period. There was no placebo comparison arm. Sertraline was initiated at 50 mg/day, and could be increased by 50 mg/day at weekly intervals based on clinical need and tolerability at the lower dose level. The blind was maintained with matching double-blind placebo capsules for the escitalopram group. Change from baseline to endpoint in MADRS total score (last observation carried forward) was the primary efficacy measure.ResultsA total of 212 patients received double-blind medication. At week 8, the mean sertraline dosage was 144 mg/day (median = 150 mg/day). Mean changes from baseline to endpoint in MADRS scores were -19.1 and -18.4 for the escitalopram and sertraline groups, respectively. At endpoint, 75% and 70% of escitalopram- and sertraline-treated patients, respectively, were responders (> or =50% improvement from baseline in mean MADRS scores). Both treatments were generally well tolerated; only 2% and 4% of patients prematurely discontinued escitalopram and sertraline treatment, respectively, due to adverse events.ConclusionNo differences in efficacy were observed for fixed-dose escitalopram 10 mg/day and sertraline flexibly dosed from 50-200 mg/day. At these doses, both escitalopram and sertraline were generally well tolerated.

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