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NCT03665038 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
A Phase 3 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 28
- Enrollment target
NCT03665038: Completed Phase 3 study, sponsored by Supernus Pharmaceuticals.
NCT03665038 is a Phase 3 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 28 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03665038, a Phase 3 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 28 participants
- Enrollment target
Study 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).
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEA
Interventions
- DRUG Brexanolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2018-09-07 |
| Est. Completion | 2021-01-08 |
| Phase | Phase 3 |
What the finished NCT03665038 record still lists
NCT03665038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Brexanolone is the first listed.
NCT03665038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03665038 about?
NCT03665038 is a clinical study titled "A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)". 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).
What is the current status of trial NCT03665038?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 28 participants. The study started on 2018-09-07. Estimated completion is 2021-01-08.
What interventions are being tested in trial NCT03665038?
The interventions under investigation include: Brexanolone (DRUG).
Who is sponsoring clinical trial NCT03665038?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03665038's enrollment target sits among peer trials
28 1935th of 2000 higher than 65 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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