A Study to Evaluate SAGE-217 in Subjects With Severe Postpartum Depression

• Status: Completed
• Trial end date: 2018-12-11
• 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-217 in approximately 140 adult female subjects diagnosed with severe postpartum depression.

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

Details

• Lead Sponsor: Sage Therapeutics

Criteria

Key Inclusion Criteria:

• Subject either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s)

• Subject 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 the Structured Clinical Interview for DSM-5 Axis I Disorders (SCID-I)

• Subject is ≤ six months postpartum

Key Exclusion Criteria:

• Active psychosis

• Attempted suicide associated with current episode of postpartum depression

• Medical history of seizures

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

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