NCT02942004

A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)

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: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.

Conditions

• Postpartum Depression

Interventions

Type	Name	Description
DRUG	Placebo	Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h.
DRUG	SAGE-547 60 μg/kg/h	Intravenous infusion of SAGE-547.
DRUG	SAGE-547 90 μg/kg/h	Intravenous infusion of SAGE-547.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-09-24
• Completion: 2017-10-19
• First posted: 2016-10-21
• Last updated: 2025-10-14
• Results posted: 2019-06-13

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study