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RECRUITING
NCT05254405
PHASE4

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

Sponsor: Donald Jeffrey Newport

View on ClinicalTrials.gov

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-06-01

Completion Date

2026-03-01

Last Updated

2024-05-22

Healthy Volunteers

No

Interventions

DRUG

Brexanolone Injection [Zulresso]

Continuous infusion of brexanolone over 60 hours titrated to a maximal dose of 90 mcg/kg/hr.

Locations (1)

University of Texas at Austin Dell Medical School

Austin, Texas, United States