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Direct Acting Antiviral
Glecaprevir/Pibrentasvir for Post-Traumatic Stress Disorder
Phase 2 & 3
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline caps score at 8 weeks
Awards & highlights
Study Summary
This trial will study if a hepatitis C drug can help reduce PTSD symptoms.
Who is the study for?
Adults aged 19-70 with PTSD, weighing at least 45 kg, eligible for Veterans Affairs healthcare can join. They must use effective birth control if applicable and be able to consent. Excluded are those with recent PTSD treatment changes, advanced liver disease, hepatitis B or current HCV infection, unstable conditions, pregnancy, severe hepatic impairment or certain drug interactions.Check my eligibility
What is being tested?
The trial is testing Glecaprevir/Pibrentasvir (GLE/PIB), a medication typically used for hepatitis C but may improve PTSD symptoms. Participants will either receive GLE/PIB or a placebo without knowing which one they're getting to compare the effects on PTSD.See study design
What are the potential side effects?
Specific side effects of GLE/PIB in the context of treating PTSD aren't detailed here; however, when used for hepatitis C it can cause headaches, fatigue and nausea among others. The study aims to identify any additional side effects related to its use in PTSD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline whodas score at 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline whodas 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)
Secondary outcome measures
World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active DrugActive Control1 Intervention
Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo, 3 oral tablets once daily for 8 weeks.
Find a Location
Who is running the clinical trial?
White River Junction Veterans Affairs Medical CenterLead Sponsor
28 Previous Clinical Trials
16,789 Total Patients Enrolled
Bradley V Watts, MD, MPHPrincipal InvestigatorUS Department of Veterans Affairs
2 Previous Clinical Trials
142 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications that are known to have serious interactions.I have been diagnosed with PTSD recently.I have had liver failure in the past.My weight is at least 45 kg.I have had hepatitis B.I have previously been treated with GLE/PIB or HCV NS5A and NS3/4A inhibitors.My liver disease is in an advanced stage.My liver function is significantly impaired.I have changed my PTSD medication in the last 2 months.I am between 19 and 70 years old.I have started or changed my PTSD therapy in the last two months.If you are capable of bearing children, it is mandatory to use an approved form of birth control (e.g., contraceptives or abstaining).
Research Study Groups:
This trial has the following groups:- Group 1: Active Drug
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05637879 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged sixty and under being accepted for participation in this clinical experiment?
"This trial requires that participants are between 19 and 70 years old. Additionally, 290 studies have enrolled people below the age of 18 while 870 trials have been conducted on individuals over 65."
Answered by AI
Are there any current opportunities for participation in this experiment?
"The clinicaltrials.gov website confirms that this medical experiment is no longer recruiting patients, having been posted on July 1st 2023 and its last update occurring in November 23rd 2022. Despite the trial's closure, there are 1247 other trials currently open to potential participants."
Answered by AI
Has Active attained regulatory approval from the FDA?
"Due to the lack of clinical data confirming Active's efficacy, its safety rating stands at a 2. However, there is evidence that it can be safely administered in controlled environments."
Answered by AI
What is the eligibility criterion to participate in this research?
"Qualifications for this medical trial include having a diagnosis of stress disorder, combat exposure, and an age range between 19-70 years old. The target recruitment goal is 92 people in total."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have ctpsd, social anxiety, acute anxiety, generalize anxiety, bi bipolar insomnia, chronic neck, back pain , synostosis.
PatientReceived 1 prior treatment
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