An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
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
• Subject has signed an ICF prior to any study-specific procedures being performed
• Subject is a premenopausal female between 18 and 50 years of age, inclusive
• 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.
• PCL-5 total score ≥ 33 at screening and baseline (Day 0)
• Subject is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead ECG, or clinical laboratory tests
• Subject agrees to adhere to the study requirements
• Subject must have a negative pregnancy test at screening and Day 1 prior to the start of study drug infusion
• Subject is willing at screening to delay the start of any new pharmacotherapy regimens, including antidepressant or anti-anxiety medication, until the study drug infusion and 72-hour assessments have been completed; if the subject is taking psychotropic medications, these must be at a stable dose from 14 days prior to screening until the 72-hour assessments have been completed.
• Fluency (oral and written) in the language in which standardized tests will be administered.
⁃ Subject must use one of the following methods of birth control during participation in the study and for 30 days following the end of the study drug infusion:
∙ Total abstinence (no sexual intercourse)
‣ Hormonal contraceptives (birth control) including birth control pills, implantable or injectable contraceptives (Norplant® or DepoProvera®)
‣ A barrier form of contraception such as a condom or occlusive cap with a spermicide
‣ An intrauterine device