At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 440 enrolled
Drug / intervention
SAGE-217 +6 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 Phase 3, Randomized, Double-Blind Study Comparing the Efficacy and Safety of SAGE-217 Plus an Antidepressant Versus Placebo Plus an Antidepressant in Adults With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating SAGE-217, Matching Placebo, and 5 other interventions for Depressive Disorder, Major. Completed, enrolled 440 participants across 51 sites.
Detailed Summary
The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartNov 2020
Primary CompletionOct 2021
Study CompletionDec 2021
TodayJul 2026
First PostedJul 17, 2020
Enrollment StartNov 9, 2020
Primary CompletionOct 25, 2021
Study CompletionDec 22, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.0 years ago
Interventions
SAGE-217drug
Oral capsules
Matching Placebodrug
Oral capsules
Sertralinedrug
Oral tablets
Escitalopramdrug
Oral tablets
Citalopramdrug
Oral tablets
Duloxetinedrug
Oral capsules
Desvenlafaxinedrug
Oral tablets