At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,515 enrolled
Drug / intervention
SAGE-217drug
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, Open-Label, 1-Year Study of the Safety, Tolerability, and Need for Re-Treatment With SAGE-217 in Adult Subjects With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating SAGE-217 for Major Depressive Disorder. Completed, enrolled 1,515 participants across 52 sites.
Detailed Summary
This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartFeb 2019
First PostedMar 2019
Primary CompletionJun 2023
TodayJul 2026
First PostedMar 6, 2019
Enrollment StartFeb 27, 2019
Primary CompletionJun 22, 2023
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.3 years ago
Interventions
SAGE-217drug
SAGE-217