At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 102 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 Phase 2, Two-Part (Open-Label Followed by Double-Blind) Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Adult Subjects With Moderate to Severe Major Depressive Disorder
In Brief
A Phase 2 clinical trial evaluating SAGE-217 and Placebo for Major Depression. Completed, enrolled 102 participants across 8 sites.
Detailed Summary
This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with moderate to severe Major Depressive Disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depression
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartDec 2016
First PostedDec 2016
Primary CompletionOct 2017
Study CompletionNov 2017
TodayJul 2026
First PostedDec 22, 2016
Enrollment StartDec 7, 2016
Primary CompletionOct 4, 2017
Study CompletionNov 8, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.5 years ago
Interventions
SAGE-217drug
Placebodrug