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

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Jul 2017

At a glance

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

    • 01 Mar 2017 Planned number of patients changed from 60 to 120.
    • 06 Dec 2016 According to a Sage Therapeutics media release, trial design for this trial is considered appropriate for registration, with increase in size and other minor modifications.
    • 03 Nov 2016 According to a SAGE Therapeutics media release, data readout from this trial is expected in the second half of 2017.
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