Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified July 2024 by White River Junction Veterans Affairs Medical Center
Sponsor
White River Junction Veterans Affairs Medical Center
Information Provided by (Responsible Party)
Bradley Watts
Clinicaltrials.gov Identifier
NCT05637879
Other Study ID Numbers:
1698661
First Submitted
November 14, 2022
First Posted
December 5, 2022
Last Update Posted
April 23, 2025
Last Verified
July 2024

ClinicalTrials.gov processed this data on April 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
PTSD
Drug: Glecaprevir/pibrentasvirOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment92 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleRandomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder
Study Start DateDecember 17, 2023
Actual Primary Completion DateDecember 30, 2025
Actual Study Completion Date4mos 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Active Drug
Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.
Drug: Glecaprevir/pibrentasvir
Direct-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection
Placebo
Placebo, 3 oral tablets once daily for 8 weeks.
Other: Placebo
Compounded, inactive pill equal in appearance to active study drug

Outcome Measures

Primary Outcome Measures
  1. Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)
    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 Outcome Measures
  1. World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)
    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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 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

Contacts and Locations

Sponsors and CollaboratorsWhite River Junction Veterans Affairs Medical Center
Locations
White River Junction VAMC | White River Junction Vermont, United States, 05001
Investigators
Principal Investigator: Bradley V Watts, MD, MPH, US Department of Veterans Affairs