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NCT05543746 · ClinicalTrials.gov registry record
Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression
A clinical trial of Postpartum Depression, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 10
- Enrollment target
- 1
- Study location
NCT05543746 is a study of Postpartum Depression that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 10 participants, below the 534-participant average among 38 other Postpartum Depression trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05543746, a study of Postpartum Depression, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Brexanolone
Study Locations (1)
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-08-05 |
| Est. Completion | 2023-11-15 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05543746
The ClinicalTrials.gov registry entry for NCT05543746 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 534-participant average among 38 other Postpartum Depression trials with a reported enrollment target (98% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Postpartum Depression appearing as the primary indexed condition, and to 1 intervention - of which Brexanolone is the first listed.
NCT05543746 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05543746 about?
NCT05543746 is a clinical study titled "Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression". 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 eligibil...
What is the current status of trial NCT05543746?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2022-08-05. Estimated completion is 2023-11-15.
What conditions does trial NCT05543746 study?
This clinical trial studies the following conditions: Postpartum Depression.
What interventions are being tested in trial NCT05543746?
The interventions under investigation include: Brexanolone (DRUG).
Who is sponsoring clinical trial NCT05543746?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05543746 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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