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临床试验/NCT03375294
NCT03375294已完成2 期

Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)

Stanford University1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
3
试验地点
1
主要终点
Number of Patients Who Met and Exceeded Response Criteria of Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

研究概览

简要总结

The purpose of this study is to understand nitrous oxide effects in post traumatic stress disorder (PTSD)

详细描述

Post traumatic stress disorder (PTSD) is a disabling mental health disorder that impacts the lives of individuals. This study aims to understand nitrous oxide's effects in PTSD.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-80
  • Veterans of the United States Uniformed Services
  • primary diagnosis of PTSD
  • sufficient severity of PTSD symptoms
  • fluency in English
  • capacity to provide informed consent

排除标准

  • psychiatric or medical conditions that make participation unsafe
  • pregnant or nursing females
  • allergy to nitrous oxide

研究组 & 干预措施

Nitrous Oxide

Experimental

PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour

干预措施: Nitrous Oxide (Drug)

结局指标

主要结局

Number of Patients Who Met and Exceeded Response Criteria of Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

时间窗: Baseline and 1 week post inhalation

Patients given CAPS-5 (Clinician Administered PTSD Scale for DSM-5), a 30-item structured interview that can be used to assess PTSD symptoms over the past week. For the CAPS-5 the minimum units are 0 and maximum units on the total scale are 80. The higher the number on the CAPS-5, the more severe the symptoms. Response was defined as at least a 12 point reduction on the CAPS-5

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolyn Rodriguez

Assistant Professor

Stanford University

研究点 (1)

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