NCT01914861Unknown不适用
Cortisol Diurnal Variation and the Risk for Developing Post Traumatic Stress Disorder
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Development of Posttraumatic stress disorder
研究概览
简要总结
The purpose of this study is to examine a possible link between the time of day of exposure to a traumatic event and the risk of developing post-traumatic stress disorder. Clinical and biological correlates will also be examined from this perspective.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons 21-65 years old, who have been exposed to an event meeting the following DSM-IV criterion for Acute Stress Disorder:
- •Criteria A.1 and A.2 At least one of Criteria B1-5A.1
- •Who provide written, informed consent to participate in the study.
排除标准
- •Physical injury that would contraindicate participation or interfere with a subject's ability to give informed consent or cooperate with the screening or collection of initial measures. Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by Abbreviated Injury Scale (AIS), or by clinical judgment;
- •Head injury involving confusion, loss of consciousness, or amnesia;
- •Medical conditions such as extreme obesity, psoriasis, herpes, Cushing's syndrome, current infectious disease, current viral disease, tuberculosis, unstable diabetes or hypertension, myasthenia gravis, and heart failure. Persons taking medications that can interfere with the HPA axis (e.g.,steroids, betablockers,indomethacin) will be excluded;
- •Weight below 45 or above 120 kg.
- •Pregnancy (in suggestive cases, a pregnancy test will be performed);
- •Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period.
- •Overt psychopathology, intoxication, or under the influence of substances.
- •Evidence or history of schizophrenia, bipolar, other psychotic condition;
- •Prior history of PTSD;
- •Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure;
- •Assessed serious suicide risk. -
结局指标
主要结局
Development of Posttraumatic stress disorder
时间窗: six months
次要结局
- Biological correlates of post-traumatic stress disorder(six months)
- correlation between development of Posttraumatice stress disorder and time of traumatic event(six months)
研究者
研究点 (1)
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