Summary:
A study to evaluate the efficacy andsafety of SAGE-217, an oral medication, in patients with severe post-partum depression. Study medication is taken for 15 days and follow-up continues for 30 additional days. A screening period is used to assess eligibility. Participants will be seen at the clinic 9 times throughout the study and will be assessed by a psychiatrist to confirm the diagnosis. All subjects will be tested for drugs and alcohol. Labs are required at most visits.
Inclusion Criteria:
- Participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (IP) on Day 1 until 7 days after the last dose of IP.
- Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT).
- Participant is ≤12 months postpartum at screening and Day 1.
Qualified Participants May Receive:
All study medication, examinations, and labs will be included. Stipends are allowed for formula and a breat pump during the study. Transportation is provided. Sitpends are paid for each completed visit. There is no out-of-pocket expense to participants.