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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-217 in the Treatment of Adult Female Subjects With Severe Postpartum Depression

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Trial Profile

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-217 in the Treatment of Adult Female Subjects With Severe Postpartum Depression

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Dec 2023

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At a glance

  • Drugs Zuranolone (Primary)
  • Indications Postnatal depression
  • Focus Registrational; Therapeutic Use
  • Acronyms ROBIN
  • 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.
    • 16 Feb 2023 According to a SAGE Therapeutics media release, company plans to present additional analysis data from this trial in 2023.
    • 06 Feb 2023 According to a SAGE Therapeutics media release, The NDA includes data from the LANDSCAPE and NEST clinical development programs as well as a Phase 2 study of zuranolone completed by Shionogi in Japan in adults with MDD. The LANDSCAPE program includes five studies of zuranolone in adults with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL). The NEST program includes two studies of zuranolone in adult women with PPD (ROBIN and SKYLARK).

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