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NCT05254405 · ClinicalTrials.gov registry record · Phase 4
An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
A Phase 4 study of Post Traumatic Stress Disorder, sponsored by Donald Jeffrey Newport.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05254405 is a Phase 4 study of Post Traumatic Stress Disorder that is actively recruiting participants, run by Donald Jeffrey Newport. The registered enrollment target is 20 participants, below the 1,117-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05254405, a Phase 4 study of Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by Donald Jeffrey Newport.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Open-label study of brexanolone infusion for the treatment of posttraumatic stress disorder in 20 adult women with PTSD. Primary Objective: To determine if brexanolone injection infused intravenously for 24 hours at up to 60 μg/kg/h reduces PTSD symptom severity in a group of non-veteran adult female subjects diagnosed with PTSD as assessed by the change from baseline in the PTSD Checklist for DSM-5 (PCL-5) total score and rate of remission at 12-weeks post infusion. Secondary Objectives * To evaluate the safety and tolerability profiles of brexanolone in this PTSD patient population as assessed by the incidence of adverse events (AEs), vital sign measurement, the Stanford Sleepiness Scale (SSS) and the Columbia Suicide Severity Rating Scale (C-SSRS). * To determine the effects of brexanolone in reducing depressive symptoms and improving functional capacity in PTSD patients as assessed by change from baseline in self-assessment Montgomery-Asberg Depression Rating Scale (MADRS-S) total score and Sheehan Disability Scale scores
Conditions Studied
Interventions
- DRUG Brexanolone Injection [Zulresso]
Study Locations (1)
Texas
- University of Texas at Austin Dell Medical School - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2026-03-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05254405
The ClinicalTrials.gov registry entry for NCT05254405 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,117-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (98% lower). The listed sponsor is Donald Jeffrey Newport, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which Brexanolone Injection [Zulresso] is the first listed.
NCT05254405 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05254405 about?
NCT05254405 is a clinical study titled "An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder". Open-label study of brexanolone infusion for the treatment of posttraumatic stress disorder in 20 adult women with PTSD. Primary Objective: To determine if brexanolone injection infused intravenously for 24 hours at up to 60 μg/kg/h reduces PTSD symptom severity in a group of non-veteran adult fem...
What is the current status of trial NCT05254405?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2023-06-01. Estimated completion is 2026-03-01.
What conditions does trial NCT05254405 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT05254405?
The interventions under investigation include: Brexanolone Injection [Zulresso] (DRUG).
Who is sponsoring clinical trial NCT05254405?
This trial is sponsored by Donald Jeffrey Newport, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05254405 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.