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 |
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
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
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