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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
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder
