An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
Status:
Not yet recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
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 60 hours at up to 90 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
Montgomery-Asberg Depression Rating Scale (MADRS) total score and Sheehan Disability
Scale scores