Randomized, 8‐week, double‐blind, placebo‐controlled trial of vortioxetine in Japanese adults with major depressive disorder, followed by a 52‐week open‐label extension trial

Abstract

Vortioxetine failed to meet significance versus placebo in the primary efficacy analysis at week 8 in the short-term study. The extension trial indicated continued improvement of depressive symptoms from baseline of this study throughout the 52-week treatment period. Vortioxetine treatment was safe and well tolerated in both studies.

Randomized, double‐blind, placebo‐controlled study to assess the efficacy and safety of vortioxetine in Japanese patients with major depressive disorder

“…The safety profile of vortioxetine in this study is consistent with other studies in both Japanese and non‐Japanese patients; the most common adverse events were gastrointestinal in nature with participants reporting an increased prevalence of nausea and vomiting compared with placebo, although the adverse events were generally mild or moderate in intensity . The prevalence of somnolence was low and also consistent with other studies .…”

“…The safety profile of vortioxetine in this study is consistent with other studies in both Japanese and non‐Japanese patients; the most common adverse events were gastrointestinal in nature with participants reporting an increased prevalence of nausea and vomiting compared with placebo, although the adverse events were generally mild or moderate in intensity . The prevalence of somnolence was low and also consistent with other studies . Vortioxetine has generally been associated with a lower prevalence of TEAE, including sexual dysfunction and TEAE leading to discontinuation, compared with other antidepressants (duloxetine and extended‐release venlafaxine) in head‐to‐head studies .…”

“…The relatively low prevalence of severe MDD may have also contributed to the relatively high baseline DSST scores, increasing the risk of a ceiling effect, as previously noted. Furthermore, the short duration of this study does not provide insight into the long‐term safety and efficacy of vortioxetine in Japanese patients; however, this has been investigated elsewhere in patients with a first or recurrent MDE . In addition, the age‐related subgroup analysis is limited by the low number of older subjects enrolled in the study, particularly subjects aged 65 years or older; the cut‐off criterion of 51 years was necessary to support a statistical analysis by age subgroup.…”

“…Another study of vortioxetine in Japanese patients also reported non‐significant numerical improvements in MADRS total score, although clinically relevant improvements were only achieved in subjects with severe depression (baseline MADRS score ≥ 30) or a recurrent major depressive episode (MDE) . Most treatment‐emergent adverse events (TEAE) were mild to moderate in severity, and comparable with the safety profile of vortioxetine in non‐Japanese patients …”

Antidepressant Medications and Weight Change: A Narrative Review

“…Consequently, weight‐neutral treatments should be the focus of future antidepressant developments. Clinical trials have suggested that ketamine and vortioxetine may be efficacious options for the treatment of MDD with minimal effects on weight (94,104) . Currently, there are no metabolic monitoring guidelines for antidepressants (compared with antipsychotics that have well‐established guidelines), and given the high risk of weight‐change effects with some agents, we should adopt similar monitoring guidelines for antidepressants balanced with resource utilization.…”