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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05543746
Status
Completed

Conditions

  • Postpartum Depression

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Brexanolone — DRUG
    Enrolled subjects will receive a 60-hour infusion of Brexanolone (BRX) according to FDA approved protocol for administration. A programmable peristaltic infusion pump will be used to ensure accurate delivery.

Study Details

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.

Key Dates

Start date
Aug 5, 2022
Status verified
Dec 2024
Primary completion
Nov 15, 2023
Completion
Nov 15, 2023

Study Design

Enrollment
10 participants (actual)

Primary Outcome Measure

Number of Successfully Analyzed EEG Recordings [ Time Frame: 4 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27599-

Find similar trials in Chapel Hill, NC

By research site
University of North Carolina· Chapel Hill, NC

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