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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 2025

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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

  • 09 Dec 2025 According to a Biogen media release, company announced that Health Canada has issued a Notice of Compliance (NOC) for ZURZUVAETM (zuranolone) for the treatment of moderate or severe postpartum depression (PPD) in adults following childbirth, based on the NEST clinical development program, which included the ROBIN and SKYLARK studies.
  • 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.

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