Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder
White River Junction Veterans Affairs Medical Center
Summary
A double-blind randomized placebo-controlled trial to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with posttraumatic stress disorder (PTSD) symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV).
Description
N=92 patients with posttraumatic stress disorder (PTSD) will be enrolled into a double-blind randomized placebo-controlled trial to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with PTSD symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV). The research is intended to test the efficacy of GLE/PIB for PTSD symptom improvement in the absence of HCV. Primary Aims: Aim 1: Determine the efficacy of GLE/PIB for PTSD symptom improvement. Aim 2: Determine the efficacy of GLE/PIB for func…
Eligibility
- Age range
- 19–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 19-70 years 2. Weight ≥ 45 kg 3. Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment 4. Eligible for Veterans Affairs healthcare 5. If person with childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required. 6. Able to read, understand, and sign the informed consent document. Exclusion (unable to participate) Criteria: 1. Pregnant or lactating person 2. Moderate or severe hepatic impairment (Child-Pugh B or C) 3. History of prior hepatic decompensation 4. Current use of drug…
Interventions
- DrugGlecaprevir/pibrentasvir
Direct-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection
- OtherPlacebo
Compounded, inactive pill equal in appearance to active study drug
Location
- White River Junction VAMCWhite River Junction, Vermont