Trials / Completed
CompletedNCT03665038
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
A Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Supernus Pharmaceuticals, Inc. · Industry
- Sex
- Female
- Age
- 15 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression (PPD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brexanolone | Administered as IV infusion. |
Timeline
- Start date
- 2018-09-07
- Primary completion
- 2021-01-08
- Completion
- 2021-01-08
- First posted
- 2018-09-11
- Last updated
- 2025-09-15
- Results posted
- 2022-08-11
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03665038. Inclusion in this directory is not an endorsement.