Εfficacy and safety of vortioxetine (Lu AA21004) in the treatment of adult patients with major depressive disorder: A systematic review and a meta‑analysis of randomized controlled trials

Vortioxetine is a novel drug for the treatment of major depressive disorder (MDD). It has been reported that vortioxetine exhibits positive effect on acute stage MDD, while it can effectively prevent recurrence MDD during maintenance period. Currently, results systematic reviews are insufficient since several efficacy measures, such as 24‑Items Hamilton Rating Scale Depression (HADRS‑24) total score and other safety factors have not evaluated. Therefore, present study aimed to evaluate different doses adult patients with via assessing more indicators. The clinical, double‑blind, parallel randomized controlled trials (RCTs) were retrieved from PubMed\Medline, EBSCO, Embase, Cochrane Library, OVID, Web Science clinical trial registration websites database inception November 2022. A two investigators independently screened included references evaluated their quality. meta‑analysis was performed using Revman 5.0 software. review registered in PROSPERO (registration no. CRD42018106343). In 11 RCTs included, 4,908 MDD. More specifically, 1,158 5‑mg group, 736 10‑mg 298 15‑mg 864 20‑mg group 1,852 placebo group. All studies randomized, double‑blinded control trials, all publications high showed 5‑, 10‑ groups exhibited significantly higher Montgomery‑Asberg (MADRS) response (≥50%) remission (≤10%) rates compared (P<0.05). pooled analysis also revealed statistically significant change HADRS‑24, MADRS, Sheehan Disability (SDS), Clinical Global Impression Scale‑Improvement (CGI‑I) HADRS‑24 rate However, no changes SDS, CGI‑I obtained (P>0.05). Furthermore, most common adverse events nausea, hyperhidrosis, insomnia vomiting, incidence which increased vortioxetine. Overall, suggested administration at 5‑20 mg effective safe 5 displayed difference SDS scores, rate. patient increasing associated good tolerance safety. Nevertheless, multi‑center, high‑quality long‑term still needed support aforementioned findings.