PTSD
Conditions
Keywords
PTSD, Antiviral, Hepatitis C
Brief 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).
Detailed 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 functioning improvement among patients with PTSD. Aim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV.
Interventions
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
Sponsors
White River Junction Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Blinded placebo-controlled randomized trial
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
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 drugs listed as having significant drug interactions on prescribing label 5. Advanced liver disease 6. Current or prior hepatitis B infection 7. Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor 8. Current HCV infection 9. Current psychosis or mania 10. Significant suicidal ideation 11. Unstable medical conditions 12. Current severe alcohol or substance use disorder (excluding nicotine) 13. Evidence-based PTSD psychotherapy changes in the past two months 14. Evidence-based PTSD medication changes in the past two months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5) | Change from Baseline CAPS score at 8 weeks | Queries the frequency and intensity of symptoms of post-traumatic stress disorder (PTSD). The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS) | Change from Baseline WHODAS score at 8 weeks | A 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-180 with a higher score indicating worse functioning. |
Countries
United States
Contacts
Primary ContactBradley V Watts, MD, MPH
Backup ContactEmily Colon, MS
Outcome results
None listed