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A 2-Part Study (Open-label Followed by Double-blind, Randomized, Placebo-controlled, Parallel Group) of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Subjects With Bipolar I/II Disorder With a Current Major Depressive Episode

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Trial Profile

A 2-Part Study (Open-label Followed by Double-blind, Randomized, Placebo-controlled, Parallel Group) of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Subjects With Bipolar I/II Disorder With a Current Major Depressive Episode

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 Dec 2023

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At a glance

  • Drugs Zuranolone (Primary)
  • Indications Bipolar I disorders; Bipolar II disorders
  • Focus Adverse reactions
  • Acronyms ARCHWAY
  • Sponsors Biogen

    • Most Recent Events

    • 24 Jul 2019 Results presented in a Sage Therapeutics media release.
    • 02 May 2019 According to a SAGE Therapeutics media release, top-line data from this study is expected in July 2019.
    • 29 Apr 2019 Status changed from recruiting to completed.

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