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:Recruiting
Conditions:Depression, Depression, Insomnia Sleep Studies, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 64
Updated:3/22/2019
Start Date:February 20, 2019
End Date:May 2020
Contact:Shaheen Lakhan, MD, PhD
Email:shaheen.lakhan@sagerx.com
Phone:617-949-5553

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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

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, with insomnia symptoms that must not have
predated the symptoms of MDD by more than 10 weeks.

3. Subject has an Insomnia Severity Index (ISI) score ≥15 (moderate to severe insomnia).

4. Subject has a MADRS score of ≥28 prior to dosing

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.
We found this trial at
12
sites
Atlanta, Georgia 30303
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Austin, Texas 78723
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Berlin, New Jersey 08009
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Garden Grove, California 92845
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Hollywood, Florida 33024
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Little Rock, Arkansas 27702
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Miami, Florida 33155
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New York, New York 10029
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Portland, Oregon 97225
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Portland, OR
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Saint Louis, Missouri 63110
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San Diego, California 92103
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Temecula, California 92591
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Temecula, CA
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