Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

PTSD Clinical Trial

Official title:

Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05637879
• Other study ID #: 1698661
• Secondary ID: W81XWH22C0147
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: May 2023
• Source: White River Junction Veterans Affairs Medical Center
• Contact: Bradley V Watts, MD, MPH
• Phone: 802-295-9363
• Email: bradley.watts[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: September 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Glecaprevir/pibrentasvir
Direct-acting antiviral, Food & Drug Administration (FDA) approved for the treatment of hepatitis C viral infection

Other:
• Placebo
Compounded, inactive pill equal in appearance to active study drug

Locations

Country	Name	City	State
United States	White River Junction VAMC	White River Junction	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
White River Junction Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline CAPS score at 8 weeks
Secondary	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.	Change from Baseline WHODAS score at 8 weeks