A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
Launched by BIOGEN · Nov 28, 2016
Trial Information
Current as of May 29, 2025
Completed
Keywords
ClinConnect Summary
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Gender
FEMALE
Eligibility criteria
- Key Inclusion Criteria:
- • Participant 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)
- • Participant 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 Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Axis I Disorders (SCID-I)
- • Participant was \<=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 was not an exclusion. Other protocol-defined inclusion/exclusion criteria might apply.
About Biogen
Biogen is a leading biotechnology company dedicated to discovering, developing, and delivering innovative therapies for neurological and neurodegenerative diseases. With a strong focus on research and development, Biogen leverages advanced science and cutting-edge technology to address the unmet needs of patients suffering from conditions such as multiple sclerosis, Alzheimer's disease, and spinal muscular atrophy. The company is committed to advancing the understanding of the underlying biology of these diseases and is actively engaged in clinical trials to evaluate new treatment options, aiming to improve patient outcomes and enhance quality of life. With a global presence and a robust pipeline of therapies, Biogen is at the forefront of innovation in the biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Orleans, Louisiana, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Pinellas Park, Florida, United States
Atlanta, Georgia, United States
Hoffman Estates, Illinois, United States
Owensboro, Kentucky, United States
Raleigh, North Carolina, United States
Houston, Texas, United States
Richardson, Texas, United States
Orem, Utah, United States
Little Rock, Arkansas, United States
Beverly Hills, California, United States
Oceanside, California, United States
Wildomar, California, United States
Washington, District Of Columbia, United States
Aventura, Florida, United States
Miami, Florida, United States
Decatur, Georgia, United States
Lake Charles, Louisiana, United States
Saint Charles, Missouri, United States
Las Vegas, Nevada, United States
Manhasset, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Providence, Rhode Island, United States
Fort Worth, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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