Objective: To evaluate the efficacy and safety of zuranolone, an investigational neuroactive steroid and GABAA receptor positive allosteric modulator, in major depressive disorder (MDD). Methods: The phase 3, double-blind, randomized, placebo-controlled MOUNTAIN study enrolled adult outpatients with DSM-5–diagnosed MDD, 17-item Hamilton Depression Rating Scale total score (HDRS-17)?≥?22, and Montgomery-Asberg Depression Rating Scale total score ≥?32. Patients were randomized to treatment with zuranolone 20 mg, zuranolone 30 mg, or placebo for 14 days, followed by an observation period (days 15–42) and an extended follow-up (days 43–182). The primary endpoint was change from baseline (CFB) in HDRS-17 at day 15. Results: 581 patients were randomized to receive zuranolone (20 mg, n?=?194; 30 mg, n?=?194) or placebo (n?=?193). Day 15 HDRS-17 least-squares mean (LSM) CFB was ?12.5 (zuranolone 30 mg) vs ?11.1 (placebo; P?=?.116). Improvement vs placebo was significant at days 3, 8, and 12 (all P?
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