CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 28 enrolled
Drug / intervention
Brexanolonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03665038
NCT03665038Phase 3Completed
CompareCT.gov

A Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression

Supernus Pharmaceuticals, Inc.·interventional·Posted Sep 11, 2018·Updated Sep 15, 2025

In Brief

A Phase 3 clinical trial evaluating Brexanolone for Post Partum Depression. Completed, enrolled 28 participants across 17 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Partum Depression
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 11, 2018
Enrollment StartSep 7, 2018
Primary CompletionJan 8, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.8 years ago

Interventions

Brexanolonedrug

Administered as IV infusion.