A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
NCT ID: NCT03665038
Last Updated: 2025-09-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
28 participants
INTERVENTIONAL
2018-09-07
2021-01-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment
NCT02013609
Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
NCT02196506
A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder
NCT03538691
Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
NCT01838681
Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
NCT02400346
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Brexanolone
Participants will receive a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.
Brexanolone
Administered as IV infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brexanolone
Administered as IV infusion.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participant is ≤6 months postpartum at screening.
Exclusion Criteria
2. Attempted suicide during current episode of PPD
3. Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
15 Years
17 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sage Investigational Site
Tempe, Arizona, United States
Sage Investigational Site
North Little Rock, Arkansas, 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
Pompano Beach, Florida, United States
Sage Investigational Site
Atlanta, Georgia, United States
Sage Investigational Site
Decatur, Georgia, United States
Sage Investigational Site
Edgewood, Kentucky, United States
Sage Investigational Site
Owensboro, Kentucky, United States
Sage Investigational Site
Flowood, Mississippi, United States
Sage Investigational Site
Jackson, Mississippi, United States
Sage Investigational Site
Chapel Hill, North Carolina, United States
Sage Investigational Site
Middleburg Heights, Ohio, United States
Sage Investigational Site
Houston, Texas, United States
Sage Investigational Site
League City, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-004356-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
547-PPD-304
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.