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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects With Severe Postpartum Depression and Adult Female Subjects With Moderate 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-547 Injection in the Treatment of Adult Female Subjects With Severe Postpartum Depression and Adult Female Subjects With Moderate Postpartum Depression

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2022

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At a glance

  • Drugs Brexanolone (Primary)
  • Indications Postnatal depression
  • Focus Registrational; Therapeutic Use
  • Acronyms Hummingbird Study; study 1
  • Sponsors Sage Therapeutics

    • Most Recent Events

    • 12 Dec 2022 Results of post hoc pooled analysis from HUMMINGBIRD clinical program evaluating Effect of brexanolone on depressive symptoms, anxiety, and insomnia in women with postpartum depression, published in the Journal of Affective Disorders
    • 01 Jul 2021 SF-36v2 was added to trials (NCT02942017 and NCT02942004) as an exploratory endpoint by protocol amendment, and therefore was completed by a subset of patients in the clinical trials.
    • 21 Mar 2020 Results assessing Population pharmacokinetics (PopPK) of brexanolone in three randomized studies, an open label study and one study of healthy lactating women, presented at the 121st Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.

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