A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sage Therapeutics

Criteria

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.

Exclusion Criteria:

• Participant is at significant risk of suicide or has attempted suicide associated with the current episode of PPD.

• Participant has active psychosis per investigator assessment.

• Participant has a medical history of nonfebrile seizures.

• Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

• Participant has a history of sleep apnea.

Note: Other protocol-defined inclusion/exclusion criteria applied.