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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: Completed Early Phase 1 study of Postpartum Psychosis, sponsored by University of North Carolina, Chapel Hill.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The PANSS is a standardized, clinical interview that rates the presence and severity of psychosis. The PANSS yields a total average symptom score, based on 30 items rated from one to seven (range=30-210). Higher scores indicate more severe symptoms.
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 |
What the finished NCT05314153 record still lists
NCT05314153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Postpartum Psychosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05314153's enrollment target sits among peer trials
10 1629th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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