A randomized, 8-week, double-blind, placebo-controlled trial of vortioxetine in Japanese adults with major depressive disorder, followed by a 52-week open-label extension trial
Psychiatry and Clinical Neurosciences Nov 24, 2017
Inoue T, et al. - The authors aimed to assess safety and efficacy of vortioxetine (5-20 mg/day) in Japanese patients with major depressive disorder in 2 phase 3 studies consisting of a short-term, 8-week, placebo-controlled, double-blind study followed by a long-term, 52-week, open-label extension study. In the short term-study, vortioxetine failed to meet significance vs placebo in the primary efficacy analysis at week 8. The extension trial showed continued improvement of depressive symptoms from baseline of this study throughout the 52-week treatment period. In both the studies, vortioxetine treatment was safe and well tolerated.
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