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A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia

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Trial Profile

A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2023

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At a glance

  • Drugs Zuranolone (Primary)
  • Indications Insomnia; Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms RAINFOREST
  • 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.
  • 08 Jan 2020 Status changed from active, no longer recruiting to suspended.

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