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临床试验/NCT03947099
NCT03947099已完成不适用

Ketamine Infusion Therapy for the Treatment of PTSD in Paramedics

Klarisana Physician Services PLLC1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
7
试验地点
1
主要终点
PHQ-9 Score to assess for symptoms of depression

研究概览

简要总结

This is an observational study to assess the change in several psychological screening tools before and after a series of six ketamine infusions in paramedics who suffer from post traumatic stress disorder as a result of working in emergency medical services.

详细描述

Working as a paramedic in a prehospital emergency medical services system (EMS) has been shown to lead to increased incidence of post traumatic stress disorder (PTSD) and increased risk of suicide in prehospital personnel. In recent years a growing body of literature has shown that ketamine hydrochloride can be an effective treatment for PTSD. This study seeks to look specifically at paramedic level emergency medical technicians ("paramedics") with PTSD related to their prehospital work and assess whether ketamine infusion therapy can be an effective treatment for them. This is an observational study where the results of psychological screening tools that are administered before and after a six-infusion series are reported. Additionally the same assessment tools will be administered again 30 days after the final treatment to measure the durability of any changes. The participants will receive the Periodic Health Questionnaire-9 (PHQ-9), the PTSD Checklist for Diagnostic and Statistical Manual, DSM-5 (PCL-5), the Alcohol Use Disorders Identification Test (AUDIT), and the Beck Anxiety Inventory (BAI) before the infusions, after the series of six, and thirty days later. Additionally, after the series of six infusions, participants will receive the Revised Mystical Experience Questionnaire-30 (RMEQ-30) and a one question survey to assess the impact of the experiential aspect of ketamine.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must have worked as a paramedic (EMT-P) on a 911 prehospital service for at least five years.
  • Must be diagnosed with post traumatic stress disorder that happened as a result of working as a paramedic
  • Diagnosis must have been made by a mental health professional
  • The symptoms of PTSD must be having a significant adverse effect on the subject's life
  • Subjects must be able to speak and read English

排除标准

  • Currently participating in another PTSD treatment program and/or research study
  • Diagnosis of psychosis
  • Uncontrolled hypertension or a history of heart failure

结局指标

主要结局

PHQ-9 Score to assess for symptoms of depression

时间窗: three weeks

Assess for an improvement in the Periodic Health Questionnaire nine (PHQ-9) score after a series of six ketamine infusions. The PHQ-9 is a nine question scale followed by a single question that assesses functional impairment. Each of the nine questions are scored on a basis of zero to four. The higher the score the more severe the symptoms of depression are. The highest score is 27 and the lowest is zero.

PCL-5 Score to assess for symptoms of PTSD

时间窗: three weeks

Assess for an improvement in the PTSD Checklist for Diagnostic and Statistical Manual version five (PCL-5) score after a series of six ketamine infusions. The PCL-5 is a 20 question scale and each question is scored on a zero to four scale. A higher score indicates more severe symptoms of PTSD. The highest score possible is 80 and the lowest is zero.

次要结局

  • Assessment of the experiential impact of ketamine therapy(three weeks)

研究者

发起方
Klarisana Physician Services PLLC
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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