A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
NCT ID: NCT02942004
Last Updated: 2025-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
138 participants
INTERVENTIONAL
2016-08-01
2017-10-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received infusion rates equivalent to either the 60 micrograms per kilogram per hour (μg/kg/h) or 90 μg/kg/h group.
Placebo
Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h.
SAGE-547 60 μg/kg/h
Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
SAGE-547 60 μg/kg/h
Intravenous infusion of SAGE-547.
SAGE-547 90 μg/kg/h
Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
SAGE-547 90 μg/kg/h
Intravenous infusion of SAGE-547.
Interventions
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Placebo
Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h.
SAGE-547 60 μg/kg/h
Intravenous infusion of SAGE-547.
SAGE-547 90 μg/kg/h
Intravenous infusion of SAGE-547.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Attempted suicide associated with index case of postpartum depression
* Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder.
18 Years
45 Years
FEMALE
No
Sponsors
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Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Helen Colquhoun, MD
Role: STUDY_DIRECTOR
Sage Therapeutics
Locations
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Sage Investigational Site
Chandler, Arizona, United States
Sage Investigational Site
Rogers, Arkansas, United States
Sage Investigational Site
Lemon Grove, California, United States
Sage Investigational Site
Orange, California, United States
Sage Investigational Site
Ventura, California, United States
Sage Investigational Site
Gainesville, Florida, United States
Sage Investigational Site
Miami, Florida, United States
Sage Investigational Site
Miramar, Florida, United States
Sage Investigational Site
Orlando, Florida, United States
Sage Investigational Site
Pensacola, Florida, United States
Sage Investigational Site
Pinellas Park, Florida, United States
Sage Investigational Site
Atlanta, Georgia, United States
Sage Investigational Site
Hoffman Estates, Illinois, United States
Sage Investigational Site
Wichita, Kansas, United States
Sage Investigational Site
Edgewood, Kentucky, United States
Sage Investigational Site
Owensboro, Kentucky, United States
Sage Investigational Site
Boston, Massachusetts, United States
Sage Investigational Site
Boston, Massachusetts, United States
Sage Investigational Site
Flowood, Mississippi, United States
Sage Investigational Site
Marlton, New Jersey, United States
Sage Investigational Site
Glen Oaks, New York, United States
Sage Investigational Site
Chapel Hill, North Carolina, United States
Sage Investigational Site
Charlotte, North Carolina, United States
Sage Investigational Site
Raleigh, North Carolina, United States
Sage Investigational Site
Columbus, Ohio, United States
Sage Investigational Site
Dayton, Ohio, United States
Sage Investigational Site
Philadelphia, Pennsylvania, United States
Sage Investigational Site
Houston, Texas, United States
Sage Investigational Site
Houston, Texas, United States
Sage Investigational Site
Richardson, Texas, United States
Sage Investigational Site
San Antonio, Texas, United States
Sage Investigational Site
Orem, Utah, United States
Countries
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References
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Gerbasi ME, Meltzer-Brody S, Acaster S, Fridman M, Bonthapally V, Hodgkins P, Kanes SJ, Eldar-Lissai A. Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making. J Womens Health (Larchmt). 2021 Mar;30(3):385-392. doi: 10.1089/jwh.2020.8483. Epub 2020 Nov 12.
Meltzer-Brody S, Colquhoun H, Riesenberg R, Epperson CN, Deligiannidis KM, Rubinow DR, Li H, Sankoh AJ, Clemson C, Schacterle A, Jonas J, Kanes S. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet. 2018 Sep 22;392(10152):1058-1070. doi: 10.1016/S0140-6736(18)31551-4. Epub 2018 Aug 31.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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547-PPD-202 B
Identifier Type: -
Identifier Source: org_study_id
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