Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
ConditionPTSD
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age19-70
SponsorWhite River Junction Veterans Affairs Medical Center
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Glecaprevir/pibrentasvir
DrugDirect-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection
Placebo
Other interventionCompounded, inactive pill equal in appearance to active study drug
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Active DrugActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeksSponsors and contacts
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Source ClinicalTrials.gov