A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder

Phase 3 Completed 581 enrolled Biogen

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (MDD).

Timeline

Start: 2018-11-19
Primary completion: 2019-09-24
Completion: 2020-03-17

Outcome

Missed primary endpoint

paper Conclusions: MOUNTAIN did not meet its primary endpoint. PMID 36811520 ↗

registry SAGE-217 Matched Placebo vs SAGE-217 30 mg; p = 0.1158; LS Mean Difference -1.4 (95% CI -3.1 to 0.3) NCT03672175 ↗

Publications

Clayton AH, Lasser R, Nandy I, Sankoh AJ, Jonas J, Kanes SJ. Zuranolone in Major Depressive Disorder: Results From MOUNTAIN-A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial. J Clin Psychiatry. 2023 Feb 20;84(2):22m14445. doi: 10.4088/JCP.22m14445.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zuranolone	Small molecule	20 mg	Oral
Subject	Zuranolone	Small molecule	30 mg	Oral