At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 35 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 2-Part Study (Open-label Followed by Double-blind, Randomized, Placebo-controlled, Parallel Group) of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Subjects With Bipolar I/II Disorder With a Current Major Depressive Episode
In Brief
A Phase 2 clinical trial evaluating SAGE-217 and Placebo for Bipolar Disorder I and 2 related conditions. Completed, enrolled 35 participants across 11 sites.
Detailed Summary
This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a current major depressive episode.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartAug 2018
First PostedOct 2018
Primary CompletionMay 2019
TodayJul 2026
First PostedOct 2, 2018
Enrollment StartAug 23, 2018
Primary CompletionMay 21, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.8 years ago
Interventions
SAGE-217drug
SAGE-217 capsule
Placebodrug
SAGE-217 matching placebo capsule