Back to resultsGlecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
Primary Purpose
PTSD
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Glecaprevir/pibrentasvir
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for PTSD focused on measuring PTSD, Antiviral, Hepatitis C
Eligibility Criteria
Inclusion Criteria: Age 19-70 years Weight ≥ 45 kg Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment Eligible for Veterans Affairs healthcare If person with 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 (unable to participate) 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
Sites / Locations
- White River Junction VAMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Drug
Placebo
Arm Description
Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.
Placebo, 3 oral tablets once daily for 8 weeks.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05637879
First Posted
November 15, 2022
Last Updated
May 19, 2023
Sponsor
White River Junction Veterans Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05637879
Brief Title
Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
Official Title
Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
September 30, 2026 (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
Data Monitoring Committee
No
5. 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).
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 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.
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
Parallel Assignment
Model Description
Blinded placebo-controlled randomized trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Drug
Arm Type
Active Comparator
Arm Description
Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 3 oral tablets once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Glecaprevir/pibrentasvir
Other Intervention Name(s)
Mavyret
Intervention Description
Direct-acting antiviral, Food & Drug Administration (FDA) approved for the treatment of hepatitis C viral infection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Compounded, inactive pill equal in appearance to active study drug
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
Secondary Outcome Measure Information:
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:
Age 19-70 years
Weight ≥ 45 kg
Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment
Eligible for Veterans Affairs healthcare
If person with 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 (unable to participate) 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
US Department of Veterans Affairs
Official's Role
Principal Investigator
Facility Information:
Facility Name
White River Junction VAMC
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05001
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
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