Glecaprevir/Pibrentasvir for the Treatment of PTSD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)
研究概览
简要总结
An open-label pilot study 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).
详细描述
To perform an open-label pilot study (N=10) 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). The specific research described in this proposal is intended to pilot GLE/PIB for N=10 patients with PTSD in the absence of HCV.
Primary Aims:
Aim 1: Determine the feasibility of testing GLE/PIB for PTSD symptoms. Aim 2: Determine the feasibility of testing GLE/PIB for functioning among patients with PTSD.
Aim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV.
Exploratory Aim: Investigate the possible biological mechanism of GLE/PIB for PTSD via blood bio-marker analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pregnant or lactating person
- •Moderate or severe hepatic impairment (Child-Pugh B or C)
- •History of prior hepatic decompensation
- •Current use of drugs listed as having significant drug interactions on prescribing label
- •Advanced liver disease
- •Current or prior hepatitis B infection
- •Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor
- •Current HCV infection
- •Current psychosis or mania
- •Significant suicidal ideation
- •Unstable medical conditions
- •Current severe alcohol or substance use disorder (excluding nicotine)
- •Evidence-based PTSD psychotherapy changes in the past two months
- •Evidence-based PTSD medication changes in the past two months
研究组 & 干预措施
Active Drug
All enrolled participants will receive Glecaprevir/Pibrentasvir
干预措施: Glecaprevir / Pibrentasvir Pill (Drug)
结局指标
主要结局
Clinical Administered Post-Traumatic Stress Disorder Scale version 5 (CAPS-5)
时间窗: Change from Baseline CAPS score at 8 weeks
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.
World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)
时间窗: Change from Baseline WHODAS score at 8 weeks
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.
次要结局
未报告次要终点
研究者
Bradley Watts
Staff Psychiatrist
White River Junction Veterans Affairs Medical Center