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

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Nov 2017

At a glance

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

    • 10 Nov 2017 Status changed from active, no longer recruiting to completed.
    • 09 Nov 2017 According to a Sage Therapeutics media release, detailed study results, including additional secondary endpoints, will be submitted for presentation at an upcoming medical meeting and for publication.
    • 09 Nov 2017 Primary endpoint has been met. (Effect of SAGE-547 on depressive symptoms in subjects with severe postpartum depression compared to placebo injection as measured by the change from baseline in Hamilton Rating Scale for Depression (HAMD) total), according to a Sage Therapeutics media release.
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