A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression

• Status: Completed
• Trial end date: 2016-06-22
• Target enrollment: 0
• Participant gender: Female

Summary

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sage Therapeutics
• Treatments: Brexanolone

Criteria

Key Inclusion Criteria:

• Participant either must have ceased lactating at Screening; or if still lactating at Screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at Screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug.

• Participant 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-IV Axis I Disorders (SCID-I).

• Participant was less than or equal to (<=) six months postpartum.

• Participant must be amenable to intravenous therapy.

Key Exclusion Criteria:

• Active psychosis.

• Attempted suicide associated with index case of postpartum depression.

• Medical history of seizures.

• Medical history of bipolar disorder.

Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion criteria may apply.