Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
X
Search
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

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top