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

Postpartum Depression Clinical Trial

Official title:
Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression: a Feasibility Study

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05543746
Study type Observational
Source University of North Carolina, Chapel Hill
Contact Rachel G Kozik
Phone 919-972-7499
Email rachel_kozik@med.unc.edu
Status Recruiting
Phase
Start date August 5, 2022
Completion date March 2024
View Details
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