Clinical Trial 42912


Atlanta, GA 30342

Study 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:

  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.

Study is Available At:

1100 Johnson Ferry Road NE Suite 420
Atlanta, GA 30342
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If you or someone you care for is interested in participating in this clinical trial and lives within 50 miles of the clinic, please complete the form below and click 'I Am Interested In This Study'

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.