Psychiatrist.comZuranolone in Major Depressive Disorder: Results From MOUNTAIN—A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial

The study enrolled 581 adult outpatients with DSM-5-diagnosed MDD, HDRS-17>=22, and >=32 on the Montgomery-Asberg Depression Rating Scale. Patients were randomly assigned to receive zuranolone 20 mg, 30 mg, or placebo for 14 days, followed by an observation period (days 15-42) and an extended follow-up period (days 43–182). The primary endpoint in HDRS-17 at day 15 was change from baseline (CFB). MOUNTAIN did not meet its primary endpoint, but there were significant rapid improvements in depressive symptoms with zuranolone 30 mg at days 3, 8, and 12, and it was generally well tolerated in patients with MDD.