Summary:
This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult subjects with comorbid major depressive disorder and insomnia
Inclusion Criteria:
- Subject has a diagnosis of MDD as diagnosed by SCID-5-CT, with symptoms that have been present for at least a 4-week period.
- Subject has a diagnosis of Insomnia that is confirmed at screening based on the DSM-5 diagnostic criteria using the SCID-5-CT.
- Subject has an Insomnia Severity Index (ISI) score ≥15 (moderate to severe insomnia).
- Subject has a MADRS score of ≥28 prior to dosingand a HAM-D total score of ≥20.
Exclusion Criteria:
- Subject has attempted suicide associated within the current episode of MDD.
- Subject had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the subject has presented for screening during the 6-month postpartum period.
- Subject has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- Subject has a medical history of seizures.
- Subject has active psychosis per Investigator assessment.
Qualified Participants May Receive:
Compensation for time and travel for all completed study visits.