Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)
Lead Sponsor:
Biogen
Conditions:
Depression, Postpartum
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.
Detailed Description
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Eligibility Criteria
Inclusion
- Participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (IP) on Day 1 until 7 days after the last dose of IP.
- 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 Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT).
- Participant is ≤12 months postpartum at screening and Day 1.
Exclusion
- Participant is at significant risk of suicide or has attempted suicide associated with the current episode of PPD.
- Participant has active psychosis per investigator assessment.
- Participant has a medical history of nonfebrile seizures.
- Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- Participant has a history of sleep apnea.
- Note: Other protocol-defined inclusion/exclusion criteria applied.
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04442503
Start Date
June 8 2020
End Date
April 12 2022
Last Update
November 30 2023
Active Locations (82)
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1
Sage Investigational Site
Scottsdale, Arizona, United States, 85258
2
Sage Investigational Site
Bentonville, Arkansas, United States, 72712
3
Sage Investigational Site
Anaheim, California, United States, 92805
4
Sage Investigational Site
Bellflower, California, United States, 90706