A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
Launched by SAGE THERAPEUTICS · Oct 20, 2016
Trial Information
Current as of May 29, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
Eligibility criteria
- Key Inclusion Criteria:
- • Participants must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s) from just prior to receiving study drug through nine days (Day 12) after the end of the infusion
- • Participants 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 had a HAM-D total score of ≥26 at screening and Day 1 (prior to dosing)
- • Participant was ≤6 months postpartum at screening
- • Participant was amenable to IV therapy
- Key Exclusion Criteria:
- • Active psychosis
- • Attempted suicide associated with index case of postpartum depression
- • Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder.
- • Note: Other protocol-defined inclusion/exclusion criteria applied.
About Sage Therapeutics
Sage Therapeutics is a biopharmaceutical company dedicated to transforming the treatment of central nervous system (CNS) disorders through innovative therapies. Focused on developing groundbreaking treatments for conditions such as depression, epilepsy, and neurodegenerative diseases, Sage leverages its expertise in neuroscience and drug development to address unmet medical needs. With a commitment to advancing patient care, the company employs a robust pipeline of novel compounds and collaborates with leading research institutions to drive scientific discovery and enhance therapeutic options for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Chapel Hill, North Carolina, United States
Columbus, Ohio, United States
San Antonio, Texas, United States
Chandler, Arizona, United States
Rogers, Arkansas, United States
Lemon Grove, California, United States
Orange, California, United States
Ventura, California, United States
Gainesville, Florida, United States
Miami, Florida, United States
Miramar, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Pinellas Park, Florida, United States
Atlanta, Georgia, United States
Hoffman Estates, Illinois, United States
Wichita, Kansas, United States
Edgewood, Kentucky, United States
Owensboro, Kentucky, United States
Flowood, Mississippi, United States
Marlton, New Jersey, United States
Glen Oaks, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Dayton, Ohio, United States
Houston, Texas, United States
Richardson, Texas, United States
Orem, Utah, United States
Patients applied
Trial Officials
Helen Colquhoun, MD
Study Director
Sage Therapeutics
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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