Treatment effect and safety of seltorexant as monotherapy for patients with major depressive disorder: a randomized, placebo-controlled clinical trial.

ABSTRACT: The antidepressant efficacy and safety of seltorexant monotherapy in major depressive disorder (MDD) was investigated in a placebo-controlled, placebo lead-in, randomized, double-blind, phase 1b study. Participants were randomized to receive seltorexant (20 mg or 40 mg) or placebo. The treatment effect was assessed by changes in the Hamilton Rating Scale for Depression-17 item (HDRS₁₇) from treatment-period baseline to week 5 in lead-in placebo non-responders ("enriched" intent-to-treat analysis set). As a secondary outcome, the effect of seltorexant on HDRS₁₇ was assessed in patients with and without subjective insomnia. Seltorexant's effects on polysomnography, serum cortisol, and cortisol waking response were also measured. In total, 128 participants were enrolled,

SUBMITTER: Mesens S 

PROVIDER: S-EPMC12092288 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature