NCT03635827Unknown2 期
A Double-Blind, Randomized, Placebo-Controlled Trial of Xenon Inhalation for Treatment of Patients With Posttraumatic Stress Disorder
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 190
- 主要终点
- CAPS-5
研究概览
简要总结
This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with PTSD.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a current diagnosis of PTSD (documented diagnosis of PTSD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5] criteria and a Clinician Administered PTSD Scale [CAPS-5] total severity score of >30).
- •Male and female patients between the ages of 18 and 85 years.
排除标准
- •History of schizophrenia, bipolar and other psychotic disorders.
- •Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma or any other respiratory conditions / diseases that may affect the respiratory function.
- •Currently undergoing PTSD-targeted psychotherapy.
- •Currently undergoing exposure-based psychotherapy for any condition.
结局指标
主要结局
CAPS-5
时间窗: Baseline to Week 6
Change in CAPS-5 score
次要结局
- PCL-5(Baseline to Week 6)
研究者
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