At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 108 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
SAGE-547 90 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.
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
In Brief
A Phase 3 clinical trial evaluating Placebo and SAGE-547 90 μg/kg/h for Postpartum Depression. Completed, enrolled 108 participants across 32 sites.
Detailed Summary
The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate 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
Enrollment StartJul 2016
First PostedOct 2016
Primary CompletionSep 2017
Study CompletionOct 2017
TodayJul 2026
First PostedOct 21, 2016
Enrollment StartJul 1, 2016
Primary CompletionSep 17, 2017
Study CompletionOct 11, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.7 years ago
Interventions
Placebodrug
Intravenous infusion of matching placebo for SAGE-547.
SAGE-547 90 μg/kg/hdrug
Intravenous infusion of SAGE-547