Status:
COMPLETED
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Conditions:
Postpartum Depression
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe...
Eligibility Criteria
Inclusion
- Adult females, 18-45 years old who experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery
- Participant has ceased lactating, or if still lactating has already fully and permanently weaned their infant; if still actively breastfeeding, participant must agree to cease giving breast milk to their infant prior to study entry
Exclusion
- 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
Key Trial Info
Start Date :
January 7 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02285504
Start Date
January 7 2015
End Date
June 5 2015
Last Update
September 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sage Investigational Site
Chapel Hill, North Carolina, United States, 27514