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A Phase 3, Randomized, Double-Blind, Placebo-controlled Study of the Efficacy and Safety of SAGE-217 With a Fixed, Repeated Treatment Regimen on Relapse Prevention in Adults With Major Depressive Disorder

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-controlled Study of the Efficacy and Safety of SAGE-217 With a Fixed, Repeated Treatment Regimen on Relapse Prevention in Adults With Major Depressive Disorder

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 30 Nov 2023

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At a glance

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

Most Recent Events

  • 03 Aug 2021 According to a SAGE Therapeutics media release, the company is formally terminating the REDWOOD and RAINFOREST Studies as , after discussing with the FDA, the company does not believe that these studies will be required for a potential NDA submission.
  • 03 Aug 2021 Status changed from suspended to discontinued, according to a SAGE Therapeutics media release.
  • 05 Jul 2021 This trial has been discontinued in Denmark (End Date: 06 Apr 2020), according to European Clinical Trials Database record.

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