跳至主要内容
临床试验/NCT05213858
NCT05213858招募中不适用

Biological Markers for Post-Traumatic Stress Disorder

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
correlation between CAPS score and mean heart rate variability

研究概览

简要总结

The current study aims to evaluate the sensitivity and specificity of a combination of various objective biomarkers for the diagnosis of PTSD.

详细描述

PTSD affects a major fraction of military combatants and is also very common in the general population. Like other psychiatric conditions, the diagnosis of PTSD is currently based on an interview and questionnaires. However, the validity of these tools is limited since it depends on the evaluator's skills, and on patient compliance and mental status; and may be prone to exaggeration or minimization of symptoms. This prompts an urgent need for evaluation that will combine biomarkers for objective diagnosis, and follow up of individuals with PTSD.

Knowledge has grown in recent years regarding the biologic pathophysiological cascade responsible for the development of a "non-healing wound in the brain" that characterizes PTSD. Shortly after the traumatic experience, fundamental changes in autonomic nervous and endocrine activity are evident, together with changes in brain function; these can become chronic in those with long-standing unremitting PTSD. Several studies indicate good correlations of the diagnosis and severity of PTSD, with objective biological measures such as heart rate variability (HRV), brain connectivity and endocrine activity. However, the currently available data on these biological variables are still not sufficient to be used for diagnosis of PTSD.

The aim of the current study is to characterize the biological fingerprint of PTSD, by using a combination of biological measures, for an objective diagnosis.

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
20 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • The willingness and ability to read, understand and sign an informed consent form.
  • Age 20-60 years.
  • A history of more than 2 years of combat service, and of at least one potentially life-threatening combat experience.
  • One year or more after the last combat experience.

排除标准

  • Inability to attend scheduled clinic visits or comply with the study protocol
  • A history of traumatic brain injury or any other known brain pathology.
  • Substance use, except for prescribed cannabis, if it can be withheld for at least 24 hours prior to the study evaluation.
  • A current psychiatric disorder other than PTSD.
  • The inability to perform an awake brain MRI.

结局指标

主要结局

correlation between CAPS score and mean heart rate variability

时间窗: at baseline

the correlation between CAPS score and mean heart rate variability will be evaluated

次要结局

  • correlation between CAPS score and frontal activity(at baseline)
  • correlation between CAPS score and fronto-limbic connectivity(at baseline)
  • correlation between CAPS score and depression score(at baseline)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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