Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
This study was previously posted by Sage Therapeutics. In July 2024, sponsorship of the trial was transferred to Biogen.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Participant has a diagnosis of MDD as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period.
2. Participant is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
3. Participant has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥28 and a HAM-D total score of ≥20 at Screening and Day 1 (prior to dosing).
You may not be if
1. Participant has attempted suicide associated with the current episode of MDD.
2. Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
3. Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.
