Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

Part of paid clinical trials in White River Junction, Vermont.

Sponsor
White River Junction Veterans Affairs Medical Center
Study ID
NCT05637879
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Glecaprevir/pibrentasvir — DRUG
    Direct-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection
  • Placebo — OTHER
    Compounded, inactive pill equal in appearance to active study drug

Study Details

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).

Key Dates

Start date
Dec 18, 2023
Status verified
Aug 2024
Primary completion
Dec 31, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Drug
    Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.
  • Placebo Comparator: Placebo
    Placebo, 3 oral tablets once daily for 8 weeks.

Primary Outcome Measure

Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5) [ Time Frame: Change from Baseline CAPS score at 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
White River Junction VAMCWhite River JunctionVermont05001
Bradley V Watts, MD
[email protected]
802-295-9363
Bradley V Watts, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in White River Junction, VT

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
White River Junction VAMC· White River Junction, VT

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