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

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Updated on 27 June 2019
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major depressive disorder

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

 

Details
Condition Insomnia, Depression (Major/Severe)
Clinical Study IdentifierTX220954
Last Modified on27 June 2019

Eligibility

 Yes No Not Sure

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, with insomnia symptoms that must not have predated the symptoms of MDD by more than 10 weeks
Subject has an Insomnia Severity Index (ISI) score ≥15 (moderate to severe insomnia)
Subject has a MADRS score of ≥28 prior to dosing

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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