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A Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of SAGE-217 in the Treatment of Adults With Severe Postpartum Depression

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Trial Profile

A Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of SAGE-217 in the Treatment of Adults With Severe Postpartum Depression

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2023

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At a glance

  • Drugs Zuranolone (Primary)
  • Indications Postnatal depression
  • Focus Registrational; Therapeutic Use
  • Acronyms SKYLARK
  • Sponsors Sage Therapeutics

Most Recent Events

  • 07 Aug 2023 According to Food and Drug Administration media release, the U.S. Food and Drug Administration (FDA) has approved the first at-home oral pill, zuranolone for treating perinatal or postpartum depression (PPD), research led by northwell health's feinstein institutes. The SKYLARK and ROBIN clinical trials - provided the research data to support the FDA's decisions.
  • 26 Jul 2023 Results published in the Feinstein Institutes for Medical Research at Northwell Health Media Release.
  • 26 Jul 2023 Results assessing efficacy and safety of zuranolone, a positive allosteric modulator of synaptic and extrasynaptic GABA(A) receptors and neuroactive steroid, as an oral, once-daily, 14-day treatment course for patients with severe postpartum depression, published in the American Journal of Psychiatry.

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