The efficacy and safety of 5 mg/d Vortioxetine compared to placebo for major depressive disorder: A meta-analysis

Objective This meta-analysis assessed the efficacy and safety of 5 mg/day vortioxetine compared to placebo for adult major depressive disorder. Methods We performed a meta-analysis of the double-blind, randomized, controlled clinical trials involving 5 mg/day vortioxetine in adult patients with major depressive disorder published on PubMed, EBSCO, and PsycINFO, and the Clinical Trials databases were searched from 2000 through October 2013. The abstracts for the Annual Meetings of the American Psychiatric Association (APA) and previous reviews were searched to identify additional studies. Results were expressed with odds ratios (ORs) with their 95 % confidence interval (CI). The effect size (ES) for the four studies was derived by computing the standardized mean difference (SMD). The data were pooled with a random effects model. Results Five RCTs met the selection criteria. Results of the meta-analysis showed the following: (1) The treatment response of 5 mg/day vortioxetine group was greater than placebo group (OR = 1.84, 95 % CI = 1.16–2.93, Z = 2.59, P = 0.010), and there was a significant antidepressant effect of vortioxetine (ES = 2.98, P = 0.001). However, there was no significant difference in remission (OR = 1.47, 95 % CI = 0.95–2.30, Z = 1.71, P = 0.090). (2) The common adverse effects included nausea, dizziness, headache, dry mouth, and diarrhea. There was a significant difference for nausea between the two groups (OR = 3.01, 95 % CI = 2.22–4.09, Z = 7.08, P = 0.00001), but no significant differences were observed for the other four adverse effects. Conclusions For the treatment of major depressive disorder, our results show that a dose of 5 mg/day vortioxetine was more effective, but more easily induced nausea, compared to placebo.