A Study to Evaluate SAGE-217 in Adult Subjects With Major Depressive Disorder



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:4/4/2019
Start Date:February 27, 2019
End Date:April 2021
Contact:Timothy Mariano, MD, PhD, MSc
Email:timothy.mariano@sagerx.com
Phone:(617) 949-5588

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A Phase 3, Open-Label, 1-Year Study of the Safety, Tolerability, and Need for Re-Treatment With SAGE-217 in Adult Subjects With Major Depressive Disorder

This is a phase 3, open-label, 1-year study of the safety, tolerability, and need for
re-treatment with SAGE-217 in adult subjects with major depressive disorder


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 is in good physical health and has no clinically significant findings, as
determined by the Investigator, on physical examination, 12-lead ECG, or clinical
laboratory tests.

Exclusion Criteria:

1. Subject has attempted suicide associated with the current episode of MDD.

2. Subject has a medical history of bipolar disorder, schizophrenia, and/or
schizoaffective disorder.

3. Subject has had vagus nerve stimulation, electroconvulsive therapy, or has taken
ketamine within the current major depressive episode.
We found this trial at
27
sites
New York, New York 10029
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Albuquerque, New Mexico 87109
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Austin, Texas 78723
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Austin, TX
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Bellevue, Washington 98007
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Bellevue, WA
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Bradenton, Florida 34201
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Bradenton, FL
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Brandon, Florida 33511
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Brandon, FL
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Brooklyn, New York 11235
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Chicago, Illinois 60612
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Chicago, IL
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Costa Mesa, California 92626
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Costa Mesa, CA
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Cromwell, Connecticut 06416
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Dallas, Texas 75251
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Dallas, TX
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Dothan, Alabama 36303
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Dothan, AL
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Lakeland, Florida 33805
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Lakeland, FL
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Lincoln, Nebraska 68526
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Lincoln, NE
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Miami, Florida 33155
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Miami, FL
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Mount Kisco, New York 10549
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Mount Kisco, NY
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Norristown, Pennsylvania 19403
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Omaha, Nebraska 68114
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Omaha, NE
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Pensacola, Florida 32502
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Princeton, New Jersey 08540
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Princeton, NJ
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Roswell, Georgia 30076
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Roswell, GA
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Saint Charles, Missouri 63304
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Saint Charles, MO
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Salem, Oregon 97301
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Salem, OR
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San Antonio, Texas 78229
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San Antonio, TX
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Shreveport, Louisiana 71101
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Shreveport, LA
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Tampa, Florida 33613
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Tampa, FL
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Woodstock, Vermont 05091
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Woodstock, VT
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