NCT05543746: BRX-PPD

Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression

Completed Results posted Last updated 28 January 2025

What this trial tests

trial testing Brexanolone in Postpartum Depression in 10 participants. Completed in 15 November 2023.

Timeline

5 August 2022

Primary endpoint
15 November 2023

15 November 2023

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Status	Completed
Study type	OBSERVATIONAL
Enrollment	10
Start date	5 August 2022
Primary completion	15 November 2023
Estimated completion	15 November 2023
Sites	1 location across United States

Drugs / interventions tested

• Brexanolone (BREXANOLONE) — full drug profile →

Conditions studied

• Postpartum Depression — all drugs for Postpartum Depression →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 18 to 45, female only, with Postpartum Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Successfully Analyzed EEG Recordings Primary · 4 days

Feasibility of EEG recordings. Each participant was scheduled to have 5 EEG recordings.

Group	Value	95% CI
Brexanolone	49

Number of Subjects Completing the Entire Study Protocol Through the Follow-up Phase Primary · 30 days

Feasibility of study completion

Group	Value	95% CI
Brexanolone	10

Number of Subjects Withdrawn From Protocol Due to Adverse Events or Participation Burden Primary · 30 days

Feasibility of subject burden

Group	Value	95% CI
Brexanolone	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug up to end of follow-up period (up to Day 30). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brexanolone

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (8 terms — click to expand)

Reaction	System	Brexanolone
Dizziness	Nervous system disorders	—
Flushing	Vascular disorders	—
Fatigue	General disorders	—
Headache	Nervous system disorders	—
Dry mouth	General disorders	—
Infusion site bruising	General disorders	—
Infusion site pain	General disorders	—
Difficulty concentrating	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT05543746 adverse events section.

Sponsor's own description

This is a feasibility study of performing repeated EEG recordings and assessment of affective states during open-label administration of BRX to women with postpartum depression. Study phases will include screening, enrollment, intervention, and follow-up. Subjects will be screened for study eligibility criteria through clinical assessments and self-report. Enrolled subjects will be admitted to the UNC Women's Hospital, where five serial EEG recordings will be obtained, along with frequent assessments of affective state, before, during, and after a 60-hour IV infusion of BRX. Follow-up procedures will include assessments of PPD and affective symptoms, as well as an exit interview with the study team. If feasibility outcomes are achieved, exploratory EEG analyses will be performed with AMICA (adaptive mixture independent component analysis), community detection, and microstate assessment. Exploratory analyses of data collected by facial expression detection software (iMotions Affectiva) are also planned.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Temporal Dynamics of Antidepressant Response Following Brexanolone Treatment in Postpartum Depression.
   Kozik R, Patterson R, Andersen E, Putnam FW, et al · · 2026 · PMID 41871269 · DOI 10.4088/jcp.25m16144