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, the company believes that the data from the trial will be sufficient to support submissions of regulatory applications seeking approval of brexanolone for PPD and plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 2018.
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top