Lead Sponsor

Biogen

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

•1. Participant had a diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT), with symptoms that had been present for at least a 4-week period.
•2. Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
•3. Participant was willing to delay the start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia \[CBT-I\]) until after study completion.

•1. Participant had attempted suicide associated with the current episode of MDD.
•2. Participant had treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) was used for this purpose.
•3. Participant had a positive pregnancy test at screening or on Day 1 prior to dosing.

Related studies

NCT07523048 · Major Depressive Disorder (MDD)

NCT07226661 · Major Depressive Disorder (MDD)

NCT07115329 · Major Depressive Disorder

NCT06793397 · Major Depressive Disorder (MDD), Depression in Adults, and more

NCT07025720 · Major Depressive Disorder (MDD), Suicidal Ideation

A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder