NCT05637879

Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: White River Junction Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-18
• Primary completion: 2025-12-31
• Completion: 2026-09-30
• First posted: 2022-12-06
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study