Anxiety & Depression Association of America

Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

Purpose

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).

Condition

PTSD

Eligibility

Eligible Ages: Between 19 Years and 70 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age 19-70 years

2. Weight ≥ 45 kg

3. Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment

4. Eligible for Veterans Affairs healthcare

5. If person with childbearing potential, use of acceptable method of birth control
(i.e., effective contraceptives, abstinence) is required.

6. Able to read, understand, and sign the informed consent document.

Exclusion (unable to participate) Criteria:

1. Pregnant or lactating person

2. Moderate or severe hepatic impairment (Child-Pugh B or C)

3. History of prior hepatic decompensation

4. Current use of drugs listed as having significant drug interactions on prescribing
label

5. Advanced liver disease

6. Current or prior hepatitis B infection

7. Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor

8. Current HCV infection

9. Current psychosis or mania

10. Significant suicidal ideation

11. Unstable medical conditions

12. Current severe alcohol or substance use disorder (excluding nicotine)

13. Evidence-based PTSD psychotherapy changes in the past two months

14. Evidence-based PTSD medication changes in the past two months

Study Design

Phase: Phase 2/Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded placebo-controlled randomized trial
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Active Drug	Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.	Drug: Glecaprevir/pibrentasvir Direct-acting antiviral, Food & Drug Administration (FDA) approved for the treatment of hepatitis C viral infection Other names: Mavyret
Placebo Comparator Placebo	Placebo, 3 oral tablets once daily for 8 weeks.	Other: Placebo Compounded, inactive pill equal in appearance to active study drug

Recruiting Locations

More Details

Status: Recruiting
Sponsor: White River Junction Veterans Affairs Medical Center

Study Contact

Bradley V Watts, MD, MPH
802-295-9363
bradley.watts@va.gov

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.