Efficacy and safety of vortioxetine for the treatment of major depressive disorder: a randomised double-blind placebo-controlled study.

ABSTRACT

Objective: This study aimed to evaluate the efficacy and adverse events of vortioxetine for Chinese patients with major depressive disorder (MDD) over 10 weeks.Methods: A total of 120 patients with MDD were randomly assigned to two groups that received vortioxetine 20 mg or placebo for 10 weeks. The outcomes were the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impressions-Improvement (CGI-I) scale, Sheehan Disability Scale (SDS) at Week 10, and the presence of adverse events.Results: A total of 113 patients completed the study. Vortioxetine showed greater efficacy than the placebo in improving MADRS, HAM-A, CGI-I, and SDS scores at Week 10. However, no significant differences were found between the groups for any treatment-emergent adverse events. No suicide related to vortioxetine treatment was recorded.Conclusions: In summary, the results of this study showed that 10 weeks of vortioxetine treatment was efficacious and well-tolerated in patients with MDD.