Clincosm LogoSign in Get a demo

Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

Sponsor
White River Junction Veterans Affairs Medical Center (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT05637879
Collaborator
(none)
92
Enrollment
1
Location
2
Arms
39
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 specific research described in this proposal 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Blinded placebo-controlled randomized trialBlinded placebo-controlled randomized trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Sep 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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
Other Names:
  • Mayvret

    		•
    Placebo Comparator: 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) [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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 White River Junction VAMC White River Junction Vermont United States 05001

    Sponsors and Collaborators

    • White River Junction Veterans Affairs Medical Center

    Investigators

    • Principal Investigator: Bradley V Watts, MD, MPH, US Department of Veterans Affairs

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bradley Watts, Staff Psychiatrist, White River Junction Veterans Affairs Medical Center
    ClinicalTrials.gov Identifier:
    NCT05637879
    Other Study ID Numbers:
    • 1698661
    • W81XWH22C0147
    First Posted:
    Dec 6, 2022
    Last Update Posted:
    Dec 14, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bradley Watts, Staff Psychiatrist, White River Junction Veterans Affairs Medical Center
    ptsd
    antiviral
    hepatitis c
    Additional relevant MeSH terms:
    Stress Disorders, Traumatic
    Stress Disorders, Post-Traumatic

    Study Results

    No Results Posted as of Dec 14, 2022