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A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder

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Trial Profile

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2023

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At a glance

  • Drugs Zuranolone (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms MOUNTAIN
  • Sponsors Sage Therapeutics

Most Recent Events

  • 05 Aug 2023 According to a SAGE Therapeutics media release, the FDA issued a Complete Response Letter for the New Drug Application (NDA) for zuranolone in the treatment of adults with major depressive disorder and stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies will be needed. Sage and Biogen are reviewing the feedback and evaluating next steps.
  • 20 Feb 2023 Results assessing the efficacy and safety of zuranolone, an investigational neuroactive steroid and GABA(A) receptor positive allosteric modulator, in major depressive disorder, published in the Journal of Clinical Psychiatry.
  • 16 Feb 2023 According to a SAGE Therapeutics media release, additional analysis of data from this study will be present in 2023.

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