Evaluate SAGE-547 in Female Patients With Severe Postpartum Depression

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, PK, and efficacy of SAGE-547 Injection in adult female patients diagnosed with severe postpartum depression (PPD).

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

Details

• Lead Sponsor: Sage Therapeutics
• Treatments: Brexanolone

Criteria

Inclusion Criteria:

• Adult females, 18-45 years old who experienced a Major Depressive Episode in the postpartum period beginning within the first 4 weeks following delivery

• Patient has ceased lactating, or if still lactating has already fully and permanently weaned their infant; if still actively breastfeeding, patient must agree to cease giving breast milk to their infant prior to study entry

Exclusion Criteria:

• Recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, or eyes, ears, or nose and throat (EENT) disorders

• Active psychosis

• Medical history of seizures