A Phase 2/3 interventional study of Glecaprevir / Pibrentasvir Pill in PTSD, sponsored by White River Junction Veterans Affairs Medical Center. Completed at 1 site in United States. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by White River Junction Veterans Affairs Medical Center · Phase 2/3, Interventional, and Treatment
An open-label pilot study 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).
To perform an open-label pilot study (N=10) 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). The specific research described in this proposal is intended to pilot GLE/PIB for N=10 patients with PTSD in the absence of HCV.
Primary Aims:
Aim 1: Determine the feasibility of testing GLE/PIB for PTSD symptoms. Aim 2: Determine the feasibility of testing GLE/PIB for functioning among patients with PTSD.
Aim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV.
Exploratory Aim: Investigate the possible biological mechanism of GLE/PIB for PTSD via blood bio-marker analyses.
Exclusion Criteria:
All enrolled participants will receive Glecaprevir/Pibrentasvir
Drug: Glecaprevir / Pibrentasvir Pill
Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.
Also known as: Mavyret
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.
Time frame: Change from Baseline CAPS score at 8 weeks
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.
Time frame: Change from Baseline WHODAS score at 8 weeks
Plan to share: No
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic→
White River Junction Veterans Affairs Medical Center