PTSDPhase 2/3NCT05637879
Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
A Phase 2/3 study testing Glecaprevir/pibrentasvir in people with PTSD, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- PTSD
- What is being tested?
- Glecaprevir/pibrentasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2023to 30 Sep 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
White River Junction VAMC
White River Junction, Vermont, 05001
Bradley V Watts, MD, 802-295-9363 ext. 5235, bradley.v.watts@dartmouth.edu
Bradley V Watts, MD
About this study
Official title: Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder
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).
Read the 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.
- Conditions
- PTSD
- Being tested
- Glecaprevir/pibrentasvir, Placebo
- Keywords
- PTSD, Antiviral, Hepatitis C
- Medical subject headings
- Stress Disorders, Post-Traumatic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glecaprevir/pibrentasvirDrug
Also called Mavyret
Direct-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection
PlaceboOther
Compounded, inactive pill equal in appearance to active study drug
| Study group | Role | What they receive |
|---|---|---|
| Active Drug | Active comparator | Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks. Receives: Drug: Glecaprevir/pibrentasvir |
| Placebo | Placebo comparator | Placebo, 3 oral tablets once daily for 8 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline CAPS score at 8 weeks
Secondary 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.
Measured: Change from Baseline WHODAS score at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start18 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded placebo-controlled randomized trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Bradley Watts, White River Junction Veterans Affairs Medical Center
- Investigators
- Bradley V Watts, MD, MPH, Principal investigator, US Department of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637879
- Sponsor's protocol ID
- 1698661
- Other IDs
- W81XWH22C0147
- Status last verified
- Aug 2024
- First submitted
- 15 Nov 2022
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT05637879
- Acronym / sponsor ID
- 1698661
- Conditions
- PTSD
- Keywords
- PTSD, Antiviral, Hepatitis C
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Blinded placebo-controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Active Drug | Active comparator | Drug: Glecaprevir/pibrentasvirGlecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo, 3 oral tablets once daily for 8 weeks. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glecaprevir/pibrentasvirAlso: MavyretDirect-acting antiviral, Food \& Drug Administration (FDA) approved for the treatment of hepatitis C viral infection | Drug | Active Drug |
| PlaceboCompounded, inactive pill equal in appearance to active study drug | Other | Placebo |
Primary outcome
Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)
Time frame: 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.
1 secondary outcome
World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)
Time frame: Change from Baseline WHODAS score at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley V Watts, MD, MPH principal investigator
US Department of Veterans Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Glecaprevir/pibrentasvir in people with PTSD, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bradley V Watts, MD, MPH (802-295-9363 ext. 5235, bradley.watts@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5) (time frame: Change from Baseline CAPS score at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.