Actively Recruiting
An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
Led by Donald Jeffrey Newport · Updated on 2024-05-22
20
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
D
Donald Jeffrey Newport
Lead Sponsor
S
Sage Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form prior to any study procedures
- Premenopausal female between 18 and 50 years old
- Current diagnosis of PTSD from civilian trauma confirmed by MINI interview
- PTSD Checklist for DSM-5 (PCL-5) score of 33 or higher at screening and baseline
- Good physical health with no significant issues on exam, ECG, or lab tests
- Agreement to follow study requirements
- Negative pregnancy test at screening and prior to infusion
- Willingness to delay new pharmacotherapy until after infusion and assessments; stable psychotropic doses for at least 14 days prior
- Fluent in the language of test administration
- Use of approved birth control methods during study and for 30 days after infusion (abstinence, hormonal contraceptives, barrier methods with spermicide, or intrauterine device)
You will not qualify if you...
- Currently pregnant, breastfeeding, or less than 6 months postpartum
- Renal failure requiring dialysis, severe liver failure, or anemia with hemoglobin 10 g/dL or less
- Allergy to progesterone, allopregnanolone, or related neuroactive steroids
- Active psychosis
- At risk of suicide or positive response to suicidal ideation questions on Columbia Suicide Severity Rating Scale
- History of bipolar disorder, schizophrenia, or schizoaffective disorder
- Substance use disorder in past 6 months or positive drug screen (except some benzodiazepines)
- History of seizure disorder
- Prior treatment with brexanolone or participation in related studies
- Use of benzodiazepines or CNS depressants; recent start of psychotropic agents within 14 days
- Any medical, psychiatric, or social condition that could interfere with the study or participant safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Texas at Austin Dell Medical School
Austin, Texas, United States, 78712
Actively Recruiting
Research Team
F
Fouzia Sheikh
CONTACT
M
Madeline Sheehan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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