![]() ![]() Results: Efficacy analyses included 276 levomilnacipran SR-treated patients and 277 placebo-treated patients. Safety was evaluated according to adverse events, laboratory investigations, and vital signs/physical findings. The primary efficacy measure was Montgomery Asberg Depression Rating Scale (MADRS) score change from baseline to week 10 secondary efficacy measures were the HDRS 17, SDS, Clinical Global Impressions-Improvement scale, and MADRS response (≥ 50% decrease from baseline) and remission (score ≤ 10). Levomilnacipran SR dose was increased to 100 mg/d over 12 days. Method: Between December 2006 and October 2007, a 10-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, flexible-dose trial assessed once-daily levomilnacipran SR (75 mg or 100 mg) in outpatients (18-70 years) meeting DSM-IV criteria for a major depressive episode (duration ≥ 1 month) with a 17-item Hamilton Depression Rating Scale (HDRS 17) score > 22 and Sheehan Disability Scale (SDS) score ≥ 10. Objective: To investigate the efficacy and safety of levomilnacipran sustained release (SR), an antidepressant candidate in late-stage development, in major depressive disorder (MDD). ![]()
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