A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
Public ClinicalTrials.gov record NCT03665038. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression
Study identification
- NCT ID
- NCT03665038
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Industry
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Interventions
- Brexanolone Drug
Drug
Eligibility (public fields only)
- Age range
- 15 Years to 17 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 6, 2018
- Primary completion
- Jan 7, 2021
- Completion
- Jan 7, 2021
- Last update posted
- Sep 14, 2025
2018 – 2021
United States locations
- U.S. sites
- 17
- U.S. states
- 9
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sage Investigational Site | Tempe | Arizona | 85226 | — |
| Sage Investigational Site | North Little Rock | Arkansas | 72758 | — |
| Sage Investigational Site | Miramar | Florida | 33029 | — |
| Sage Investigational Site | Orlando | Florida | 32807 | — |
| Sage Investigational Site | Pensacola | Florida | 32502 | — |
| Sage Investigational Site | Pinellas Park | Florida | 33782 | — |
| Sage Investigational Site | Pompano Beach | Florida | 33060 | — |
| Sage Investigational Site | Atlanta | Georgia | 30331 | — |
| Sage Investigational Site | Decatur | Georgia | 30030 | — |
| Sage Investigational Site | Edgewood | Kentucky | 41017 | — |
| Sage Investigational Site | Owensboro | Kentucky | 42303 | — |
| Sage Investigational Site | Flowood | Mississippi | 39232 | — |
| Sage Investigational Site | Jackson | Mississippi | 39216 | — |
| Sage Investigational Site | Chapel Hill | North Carolina | 27599 | — |
| Sage Investigational Site | Middleburg Heights | Ohio | 44130 | — |
| Sage Investigational Site | Houston | Texas | 77058 | — |
| Sage Investigational Site | League City | Texas | 77573 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03665038, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 14, 2025 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03665038 live on ClinicalTrials.gov.