Study of SAGE-217 in the Treatment of Severe PPD
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of SAGE-217 in the Treatment of Adults with Severe Postpartum Depression
IRAS ID
287176
Contact name
Rupert McShane
Contact email
Sponsor organisation
Sage Therapeutics, Inc.
Eudract number
2020-001424-34
Duration of Study in the UK
0 years, 10 months, 15 days
Research summary
The purpose of this study is to test an investigational medicinal product called SAGE-217 to determine if it reduces depressive symptoms in patients with Post Partum Depression (PPD) compared to placebo.
Postpartum depression (PPD) is defined as the occurrence of major depressive episode within 4 weeks before delivery or up to a year after giving birth. The estimated prevalence of PPD in the UK is more than 1 woman in 10 within a year of giving birth.
Based on data from several studies, approximately 25% of PPD cases are considered severe. If untreated, PPD can have devastating consequences for the woman and her family.
PPD is characterised by significant functional impairment for the mother due to sadness and depressed mood, loss of interest in daily activities, changes in eating and sleeping habits, fatigue and decreased energy, inability to concentrate, and feelings of worthlessness, shame, or guilt. Postpartum depression also carries an increased risk for suicide which is the leading cause of maternal death following childbirth in developed countries.
Current types of treatment for severe PPD comprises use of psychotherapy, self-help strategies, and medication.
Participants will be in the study for up to 76 days (up to a 28-day Screening Period, a 14-day Treatment Period, and a 34 day follow-up period). Participants will be randomly assigned on a 1:1 ratio to receive either SAGE-217 or placebo. Participants will need to take SAGE-217 or placebo either within 1 hour of an evening meal containing fat, or with a fat-containing snack, at approximately 8pm each day.REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/1044
Date of REC Opinion
4 Nov 2020
REC opinion
Further Information Favourable Opinion