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Direct Acting Antiviral
Glecaprevir/Pibrentasvir for PTSD
Phase 2 & 3
Recruiting
Led By Bradley V Watts, MD, MPH
Research Sponsored by White River Junction Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight ≥ 45 kg
Age 19-70 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline whodas score at 8 weeks
Awards & highlights
Study Summary
This trial will investigate whether the DAA glecaprevir/pibrentasvir can help improve symptoms of PTSD in patients with HCV.
Who is the study for?
This trial is for adults aged 19-70 with PTSD, weighing at least 45 kg, and eligible for Veterans Affairs healthcare. Participants must use effective birth control if applicable and be able to consent. Exclusions include severe liver disease, certain drug interactions, heavy alcohol or substance abuse, pregnancy, current psychosis or mania, recent changes in PTSD treatments.Check my eligibility
What is being tested?
The study tests Glecaprevir/Pibrentasvir (GLE/PIB) pills on individuals with PTSD. It's an open-label pilot study which means everyone knows they're getting the medication that was previously noted to improve PTSD symptoms when used for chronic hepatitis C.See study design
What are the potential side effects?
While specific side effects are not listed here for GLE/PIB in treating PTSD, common ones from its use in hepatitis C may include headache, fatigue and nausea. Side effects can vary based on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 45 kg.
Select...
I am between 19 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline caps score at 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline caps score at 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)
World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Active DrugExperimental Treatment1 Intervention
All enrolled participants will receive Glecaprevir/Pibrentasvir
Find a Location
Who is running the clinical trial?
White River Junction Veterans Affairs Medical CenterLead Sponsor
28 Previous Clinical Trials
16,871 Total Patients Enrolled
Bradley V Watts, MD, MPHPrincipal InvestigatorWhite River Junction Veterans Affairs Medical Center
2 Previous Clinical Trials
224 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver disease is in an advanced stage.My liver function is moderately or severely impaired.I have started or changed my PTSD therapy in the last two months.I have had hepatitis B.I have had liver failure in the past.You are experiencing strong thoughts about hurting yourself or ending your life.I have been diagnosed with PTSD recently.You are currently experiencing severe mental health issues like hallucinations or extreme mood swings.I have previously been treated with GLE/PIB or similar hepatitis C medications.I weigh at least 45 kg.I am between 19 and 70 years old.I am currently taking medication that has major interaction warnings.You have a serious problem with alcohol or drugs (excluding smoking).I have changed my PTSD medication in the last two months based on medical advice.
Research Study Groups:
This trial has the following groups:- Group 1: Active Drug
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For which patients is this drug test appropriate?
"Eligible participants for this study should have moral injury and be between 19 and 70 years old. The clinical trial is admitting around 10 candidates."
Answered by AI
Are there any spots left in this experiment for new test subjects?
"Unfortunately, this particular clinical trial is not looking for anymore patients at the moment. Although, there are other 351 trials that are still enrolling individuals. This specific study was posted on August 1st 2022 and last updated on July 1st of the same year."
Answered by AI
Will this research be looking at patients who are over 50 years old?
"According to the research, only patients aged 19-70 are eligible for this trial. There are 36 trials for people under 18 and 282 for those over 65."
Answered by AI
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