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NCT05314153 · ClinicalTrials.gov registry record · Early Phase 1
Effects Zulresso on Postpartum Psychosis
A Early Phase 1 study of Postpartum Psychosis, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05314153 is a Early Phase 1 study of Postpartum Psychosis that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05314153, a Early Phase 1 study of Postpartum Psychosis, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, proof of concept trial to investigate the efficacy, safety and tolerability of Zulresso (brexanolone) administered to adult female subjects diagnosed with postpartum psychosis. This study will provide critical pilot data to determine whether there is similar treatment efficacy among patients with postpartum psychosis as observed to date in patients with postpartum depression.
Conditions Studied
Interventions
- DRUG Brexanolone
Study Locations (1)
North Carolina
- UNC Hospitals - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-02-23 |
| Est. Completion | 2024-06-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05314153
The ClinicalTrials.gov registry entry for NCT05314153 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 Psychosis appearing as the primary indexed condition, and to 1 intervention - of which Brexanolone is the first listed.
NCT05314153 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05314153 about?
NCT05314153 is a clinical study titled "Effects Zulresso on Postpartum Psychosis". This is an open-label, proof of concept trial to investigate the efficacy, safety and tolerability of Zulresso (brexanolone) administered to adult female subjects diagnosed with postpartum psychosis. This study will provide critical pilot data to determine whether there is similar treatment efficacy...
What is the current status of trial NCT05314153?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2022-02-23. Estimated completion is 2024-06-01.
What conditions does trial NCT05314153 study?
This clinical trial studies the following conditions: Postpartum Psychosis.
What interventions are being tested in trial NCT05314153?
The interventions under investigation include: Brexanolone (DRUG).
Who is sponsoring clinical trial NCT05314153?
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 NCT05314153 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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