CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 138 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
SAGE-547 60 μg/kg/hfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02942004
NCT02942004Phase 3Completed
CompareCT.gov

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

Supernus Pharmaceuticals, Inc.·interventional·Posted Oct 21, 2016·Updated Oct 14, 2025

In Brief

A Phase 3 clinical trial evaluating Placebo, SAGE-547 60 μg/kg/h, and 1 other intervention for Postpartum Depression. Completed, enrolled 138 participants across 32 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostpartum Depression
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 21, 2016
Enrollment StartAug 1, 2016
Primary CompletionSep 24, 2017
Study CompletionOct 19, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.7 years ago

Interventions

Placebodrug

Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h.

SAGE-547 60 μg/kg/hdrug

Intravenous infusion of SAGE-547.

SAGE-547 90 μg/kg/hdrug

Intravenous infusion of SAGE-547.