Vortioxetine vs placebo in major depressive disorder: A systematic review and meta-analysis of double-blind, randomized, placebo-controlled, phase 3 trials in Japan.

T. Inoue et al. (see record [rid]2020-09913-002[/rid]) reported that both vortioxetine 10 mg/day (VOR10) and 20 mg/day (VOR20) were superior to placebo in efficacy outcomes for Japanese patients with major depressive disorder (MDD). Based on the evidence presented, VOR was approved for MDD treatment in Japan. However, two other double-blind, randomized, placebo-controlled, phase 3 trials (DBRPCP3T) of VOR for MDD in Japan showed that VOR was not superior to placebo in efficacy outcomes. Those trials were reported by T. Inoue et al. (see record [rid]2017-58272-001[/rid]) and A. Nishimura et al. (see record [rid]2017-45023-001[/rid]). The results of efficacy among three Japan DBRPCP3T are inconsistent. Therefore, in the current study a systematic review and meta-analysis to investigate the true benefits and efficacy of VOR in Japanese patients with MDD is performed. The systemic literature review was based on the patient, intervention, comparison, and outcome (PICO) strategy. The meta-analysis demonstrated that both VOL10 and VOL20 facilitated a significant benefit for MDD treatment in Japanese patients, as reported by T. Inoue et al.