An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
Donald Jeffrey Newport
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
Description
Study Design and Methodology: Open label study enrolling 20 subjects in which diagnosis of PTSD will be established, PTSD and depressive symptom severity will be assessed with validated psychometric instruments. Patient will be treated with continuous IV infusions of brexanolone at our affiliate hospital, Ascension Seton Medical Center, using an attenuated version of the intravenous dose regimen previously approved by the FDA for postpartum depression. Following infusion, follow-up visits will be conducted for 12 weeks after the infusion. Subjects must remain as inpatients during the study Tr…
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject has signed an ICF prior to any study-specific procedures being performed 2. Subject is a premenopausal female between 18 and 50 years of age, inclusive 3. Subject has a current diagnosis of PTSD associated with civilian (i.e., non-military) trauma according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI) at the screening visit. 4. PCL-5 total score ≥ 33 at screening and baseline (Day 0) 5. Subject is in good physical health and has no clinically significant fi…
Interventions
- DrugBrexanolone Injection [Zulresso]
Continuous infusion of brexanolone over 60 hours titrated to a maximal dose of 90 mcg/kg/hr.
Location
- University of Texas at Austin Dell Medical SchoolAustin, Texas