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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: Recruiting Phase 4 study of Post Traumatic Stress Disorder, sponsored by Donald Jeffrey Newport.
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 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The primary efficacy outcome measure is change in PTSD Checklist for DSM-5 (PCL-5) total score from baseline at study endpoint (i.e., Week 12/Day 90). The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD.
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 |
What NCT05254405 shows while recruiting
NCT05254405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05254405's enrollment target sits among peer trials
20 231st of 262 higher than 22 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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.
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