The efficacy and safety of 10 mg/day vortioxetine compared to placebo for adult major depressive disorder: a meta-analysis

Background: There is a growing interest in vortioxetine in major depressive disorder (MDD). Objectives: This meta-analysis aimed to assess the efficacy and safety of 10 mg/day (mg/d) vortioxetine compared to placebo for MDD in adult. Methods: Eight randomly controlled trials (RCTs) about the treatment of 10 mg/d vortioxetine in adult patients with MDD were identified and 2354 patients were included in meta-analysis. Results: According to the results, 10 mg/d vortioxetine showed significant differences in response rates (OR=1.88, 95% CI=1.40-2.53, P<0.0001), remission rates (OR=1.54, 95% CI=1.27-1.86, P<0.00001), change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score (SMD=-3.50, 95% CI=-4.83 to -2.17, P<0.00001), clinical global Impression-Global Improvement (CGI-I) total score (SMD=-3.40, 95% CI=-4.69 to -2.11, P<0.00001), and change from baseline in Sheehan Disability Scale (SDS) total score (SMD=-2.09, 95% CI=-2.64 to -1.55, P<0.00001). But 10 mg/d vortioxetine was easier induced nausea (OR=4.18, 95% CI=3.21-5.44, P<0.00001) and constipation (OR=1.88, 95% CI=1.14 to 3.09, P=0.01). Conclusion: 10 mg/d vortioxetine was more effective, but easily induced nausea and constipation when compared to placebo for MDD in adult.