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A Phase 3, Randomized, Double-Blind Study Comparing the Efficacy and Safety of SAGE-217 Plus an Antidepressant Versus Placebo Plus an Antidepressant in Adults With Major Depressive Disorder

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Trial Profile

A Phase 3, Randomized, Double-Blind Study Comparing the Efficacy and Safety of SAGE-217 Plus an Antidepressant Versus Placebo Plus an Antidepressant in Adults With Major Depressive Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Dec 2023

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At a glance

  • Drugs Zuranolone (Primary) ; Citalopram; Desvenlafaxine; Duloxetine; Escitalopram; Sertraline
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms CORAL
  • 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.
    • 16 Feb 2023 According to a SAGE Therapeutics media release, increase in R&D expenses was partially offset by completion of this study.
    • 16 Feb 2023 According to a Sage Therapeutics media release, company plans to present additional analysis data from this study in 2023.
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