A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)

• Status: Completed
• Trial end date: 2021-01-08
• Target enrollment: 0
• Participant gender: Female

Summary

This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression.

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

Details

• Lead Sponsor: Sage Therapeutics
• Treatments: Brexanolone

Criteria

Key Inclusion Criteria:

1. 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 DSM-5 Disorders (SCID-5).

2. Participant is ≤6 months postpartum at screening.

Key Exclusion Criteria:

1. Active psychosis

2. Attempted suicide during current episode of PPD

3. Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Note: Other protocol-defined inclusion/exclusion criteria may apply.