Clinical Trial 42912

Atlanta, GA 30342


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:

  1. 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.
  2. Subject has a diagnosis of Insomnia that is confirmed at screening based on the DSM-5 diagnostic criteria using the SCID-5-CT.
  3. Subject has an Insomnia Severity Index (ISI) score ≥15 (moderate to severe insomnia).
  4. Subject has a MADRS score of ≥28 prior to dosingand a HAM-D total score of ≥20.

Exclusion Criteria:

  1. Subject has attempted suicide associated within the current episode of MDD.
  2. 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.
  3. Subject has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
  4. Subject has a medical history of seizures.
  5. Subject has active psychosis per Investigator assessment.

Qualified Participants May Receive:

Compensation for time and travel for all completed study visits.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.