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Glecaprevir/Pibrentasvir for the Treatment of PTSD

Primary Purpose

PTSD

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Glecaprevir / Pibrentasvir Pill
Sponsored by
White River Junction Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Antiviral, Hepatitis C

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Summary

  1. Age 19-70 years
  2. Weight ≥ 45 kg
  3. PTSD as determined by the CAPS within seven days of enrollment.
  4. Eligible for VA healthcare.
  5. If female 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:

  1. Pregnant or lactating woman
  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 (HBV) 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. VA/DoD Clinical Practice Guideline first-line psychotherapy changes in the past two months
  14. Evidence-based PTSD medication changes in the past two months

Sites / Locations

  • White River Junction VAMCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Drug

Arm Description

All enrolled participants will receive Glecaprevir/Pibrentasvir

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 1, 2022
Last Updated
May 19, 2023
Sponsor
White River Junction Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05446857
Brief Title
Glecaprevir/Pibrentasvir for the Treatment of PTSD
Official Title
Glecaprevir/Pibrentasvir for the Treatment of PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
White River Junction Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, Antiviral, Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Drug
Arm Type
Experimental
Arm Description
All enrolled participants will receive Glecaprevir/Pibrentasvir
Intervention Type
Drug
Intervention Name(s)
Glecaprevir / Pibrentasvir Pill
Other Intervention Name(s)
Mavyret
Intervention Description
Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.
Primary Outcome Measure Information:
Title
Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)
Description
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
Title
World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Summary Age 19-70 years Weight ≥ 45 kg PTSD as determined by the CAPS within seven days of enrollment. Eligible for Veterans Affairs healthcare. If of childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required. Able to read, understand, and sign the informed consent document. Exclusion Criteria: Pregnant or lactating person Moderate or severe hepatic impairment (Child-Pugh B or C) History of prior hepatic decompensation Current use of drugs listed as having significant drug interactions on prescribing label Advanced liver disease Current or prior hepatitis B infection Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor Current HCV infection Current psychosis or mania Significant suicidal ideation Unstable medical conditions Current severe alcohol or substance use disorder (excluding nicotine) Evidence-based PTSD psychotherapy changes in the past two months Evidence-based PTSD medication changes in the past two months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bradley V Watts, MD, MPH
Phone
802-295-9363
Ext
5235
Email
bradley.watts@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica E Hoyt, MPH
Phone
802-295-9363
Email
jessica.hoyt2@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley V Watts, MD, MPH
Organizational Affiliation
White River Junction Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
White River Junction VAMC
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Rivera
Phone
802-295-9363
Ext
5373
Email
diana.rivera@va.gov
First Name & Middle Initial & Last Name & Degree
Cory Gaudette
Phone
802-295-9363
Ext
6880
Email
cory.gaudette@va.gov
First Name & Middle Initial & Last Name & Degree
Bradley V Watts, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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Glecaprevir/Pibrentasvir for the Treatment of PTSD

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