Evaluation Efficacy and Safety of Vortioxetine 20 mg/d versus Placebo for Treatment Major Depressive Disorder: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract

Major depressive disorder, a common debilitating illness, is one of the leading causes of disability and disease worldwide. Different drugs for the treatment of patients with major depression can be used. Vortioxetine for the treatment of major depressive disorder was approved by the Food and Drug Administration (FDA) in 2013. This study aimed to evaluation efficacy and safety Vortioxetine 20 mg/d compared placebo in major depressive disorder. To conduct this study, we searched Pub Med, Cochrane library, Scopus, and Central Register of Controlled Trials. This study by including randomized controlled trials (RCTs) that evaluated this study by including randomized controlled trials (RCTs) that evaluated Vortioxetine 20 mg/d in patients with major depressive disorder. Data analysis was conducted by standard mean different ratios (SMD) with 95% confidence intervals (CIs), P values and odds ratios (ORs) for adverse events with 95% confidence intervals (CIs) and P values; heterogeneity testing and sensitivity analysis was also performed in this study. We found that 4 articles met the inclusion criteria and were finally used for this meta-analysis. Results showed statistical significance in the MADRS (Montgomery-Åsberg Depression Rating Scale), SMD = −4.75 with 95% CI [−6.84, −2.65] and P value < 0.00001), for Clinical Global Impression Scale-Improvement (CGI-I) SMD was −4.34 with 95% CI [−6.41, −2.27] and P value < 0.00001, and for Sheehan Disability Scale (SDS) SMD was −2.62 with 95% CI [−3.99, −1.25] and P value < 0.00001. The pooled analysis for safety demonstrated for diarrhea OR = 0.92 with 95% CI [0.46, 1.83] , P value = 0.09, for dry mouth OR = 1.74 with 95% CI [1.07, 2.83] , P value = 0.80, for dizziness OR = 1.62 with 95% CI [0.72, 3.66] , P value = 0.05, for fatigue OR = 1.17 with 95% CI [0.34, 4.08], P value = 0.07, for headache OR = 1.28 with 95% CI [0.91, 1.79], P value = 0.60 and for nausea OR = 4.78 with 95% CI [3.43, 6.67], P value = 0.61.