At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 200 enrolled
Drug / intervention
SAGE-217 +1 moredrug
Likely dose
Not stated in 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 Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of SAGE-217 in the Treatment of Adults With Severe Postpartum Depression
In Brief
A Phase 3 clinical trial evaluating SAGE-217 and Placebo for Depression, Postpartum. Completed, enrolled 200 participants across 82 sites in 3 countries.
Detailed Summary
The purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Postpartum
CountriesSpain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartJun 2020
First PostedJun 2020
Primary CompletionMar 2022
Study CompletionApr 2022
TodayJul 2026
First PostedJun 22, 2020
Enrollment StartJun 8, 2020
Primary CompletionMar 15, 2022
Study CompletionApr 12, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.0 years ago
Interventions
SAGE-217drug
SAGE-217 oral capsules.
Placebodrug
SAGE-217 matched-placebo oral capsules.