Randomized Controlled Trial of Glecaprevir/Pibrentasvir for the Treatment of Post-traumatic Stress Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 92
- 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
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 19-70 years
- •Weight ≥ 45 kg
- •Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment
- •Eligible for Veterans Affairs healthcare
- •If person with childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required.
- •Able to read, understand, and sign the informed consent document.
- •Exclusion (unable to participate) Criteria:
- •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
排除标准
- 未提供
研究组 & 干预措施
Active Drug
Glecaprevir 100 mg/Pibrentasvir 40 mg, 3 oral tablets once daily for 8 weeks.
干预措施: Glecaprevir/pibrentasvir (Drug)
Placebo
Placebo, 3 oral tablets once daily for 8 weeks.
干预措施: Placebo (Other)
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.
次要结局
- World Health Organization Disability Assessment Schedule, version 2.0 (WHODAS)(Change from Baseline WHODAS score at 8 weeks)
研究者
Bradley Watts
Staff Psychiatrist
White River Junction Veterans Affairs Medical Center