Original Research J Clin Psychiatry February 2023

Zuranolone in Major Depressive Disorder: Results From MOUNTAIN—A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

JCP 2023;84(2):10.4088/JCP.22m14445

Full Article Read the complete peer-reviewed article in J Clin Psychiatry. Clinical Summary Many patients with major depressive disorder need faster symptom relief than standard antidepressants typically provide, but rapid-acting options must still show durable benefit and acceptable tolerability. This trial tests whether a 14-day oral course of zuranolone can deliver that rapid benefit in adult outpatients with major depressive disorder. FAQ Did zuranolone work for major depressive disorder in the phase 3 MOUNTAIN trial?

Key Takeaways In the modified full analysis set, the phase 3 trial was negative at the prespecified primary endpoint: day 15 HDRS-17 change was −12.5 (0.68) with zuranolone 30 mg versus −11.1 (0.59) with placebo, with an LSM (SE) difference of −1.4 [0.89] (P = .116). Clinical Guide How can clinicians identify adult outpatients with major depressive disorder who most closely resemble the patients with the strongest zuranolone 30 mg signal in MOUNTAIN?