Using glecaprevir/pibrentasvir to treat PTSD symptoms
Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder
This study is testing if a combination of two antiviral medications can help improve symptoms and daily functioning in people with PTSD.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | White River Junction Veterans Affairs Medical Center Federal |
| Locations | 1 site (White River Junction, Vermont) |
| Trial ID | NCT05637879 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a double-blind randomized placebo-controlled study involving 92 patients diagnosed with posttraumatic stress disorder (PTSD). It aims to evaluate the efficacy of glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral previously linked to symptom improvement in PTSD when used for chronic hepatitis C treatment. The study will assess both symptom and functioning improvement in participants, as well as the safety and tolerability of GLE/PIB in the absence of hepatitis C. Participants will be monitored for changes in PTSD symptoms and overall functioning throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19-70 with a diagnosis of PTSD who are eligible for Veterans Affairs healthcare.
Not a fit: Patients who are pregnant, have significant liver disease, or current severe substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from PTSD.
How similar studies have performed: While the use of GLE/PIB for PTSD is novel, previous studies have shown potential symptom improvement in PTSD when treated with antiviral therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
White River Junction, Vermont
- White River Junction VAMC — White River Junction, Vermont, United States (Recruiting)
Study contacts
- Principal investigator: Bradley V Watts, MD, MPH — US Department of Veterans Affairs
- Study coordinator: Bradley V Watts, MD, MPH
- Email: bradley.watts@va.gov
- Phone: 802-295-9363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.