An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder

Part of paid clinical trials in Austin, Texas.

Sponsor
Donald Jeffrey Newport
Study ID
NCT05254405
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Jun 1, 2023
Status verified
May 2026
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open-Label Infusion of Brexanolone
    This is a single arm pilot study of open label brexanolone delivered intravenously over a continuous 60-hour period. Infusions will be administered in a certified healthcare setting in accordance with the Zulresso™ dosing, administration and safety guidelines.

Primary Outcome Measure

Change in PTSD Symptom Severity: PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Through study endpoint (Week 12 / Day 90) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas at Austin Dell Medical SchoolAustinTexas78712-

Find similar trials in Austin, TX

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Texas at Austin Dell Medical School· Austin, TX

Related Studies