A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia

• Status: Terminated
• Trial end date: 2020-01-17
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sage Therapeutics

Criteria

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.