NCT04432155Unknown2 期
A Double-Blind, Randomized, Placebo-Controlled Trial of Xenon Inhalation for Treatment of Patients With Panic Disorder
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 主要终点
- PDSS
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 panic disorder.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of panic disorder according to DSM-
- •Male and female patients ≥18 years of age.
排除标准
- •History of schizophrenia, bipolar and other psychotic disorders.
- •Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma, severe lung disease and/or baseline oxygen saturations <92% or any other respiratory conditions / diseases that may affect the respiratory function.
- •Currently undergoing targeted empirically-driven psychotherapy for panic disorder or panic disorder-related symptoms.
- •Currently undergoing exposure-based psychotherapy for any condition.
研究组 & 干预措施
Placebo
Placebo Comparator
Combination Product: Placebo The placebo medical gas consists of 30% oxygen and 70% nitrogen. The dose of placebo medical gas is 10 L by volume.
干预措施: Placebo (Drug)
NBTX-001
Experimental
Combination Product: NBTX-001 Xenon Inhaler The NBTX-001 medical gas consists of 30% xenon, 30% oxygen, and 40% nitrogen. The dose of medical gas is 10 L by volume.
干预措施: Xenon (Drug)
结局指标
主要结局
PDSS
时间窗: Baseline to Week 6
Panic Disorder Severity Scale
次要结局
- PHQ-9(Baseline to Week 6)
研究者
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