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 November 2023, sponsorship of the trial was transferred to Biogen.
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period
17-item Hamilton Rating Scale for Depression (HAM-D-17) total score of ≥24 at Screening and Day 1
Participant 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
You may not be if
Has attempted suicide associated with the current episode of MDD
Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period
Participant has treatment-resistant depression
History of bipolar disorder, schizophrenia, and/or schizoaffective disorder
Known allergy to SAGE-217, allopregnanolone, or related compounds
Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine within 60 days prior to Day 1
