Dexamethasone as an Immediate Intervention
2017年12月12日 更新者：NYU Langone Health
Dexamethasone as an Immediate Intervention to Reduce Long-Term Stress Responses
To determine if a single dose of dexamethasone (5 mg) administered in the first 12 hours following a potentially traumatic event alters a) cortisol and FKBP5 RNA the next day in the periphery measured in saliva; b) FKBP5 methylation by 1 month; c) executive functioning and emotion regulation functioning; d) psychophysiological (heart rate, respiration, skin conductance) in response cued reminders of the trauma; e) enhances the likelihood of remission of PTSD symptom severity.
研究概览
研究类型
介入性
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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New York
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New York、New York、美国、10016
- New York University Medical Center
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults 18-70 years
- Evidence of acute Post Traumatic Event (PTE) exposure defined by Diagnostic and Statistical Manual criterion 'A'
- Evidence of a significant stress response defined by DSM V PTSD criterion 'B' and meeting at least criteria for 'partial PTSD' or a minimum of 3 of 4 DSM V PTSD symptom criterion
- Score of 60 or higher on the Subjective Units of Distress Scale (SUDS)
- Living in New York tri-state area
- Fluency in English, Spanish
Exclusion Criteria:
- Admission to an intensive care unit or other overnight admission
- In the Emergency Department for more than 6 hours
- Evidence of ongoing traumatic exposure (e.g. domestic violence)
- Evidence of psychotic symptoms
- Evidence of homicidality/suicidality
- Adults with an open head injury, a positive CT scan, loss of consciousness >30 seconds or survivors in a coma
- Adults in police custody or Department of Correction (DOC) patients
- Inability to understand the study's procedures, risks, or side effects, or otherwise unable to give informed consent.
- Females who are nursing or pregnant (as confirmed by a positive urine pregnancy test).
- Permanent cardiac pacer implant.
- . Self-reported medical conditions that may be affected by DEX including asthma, epilepsy,diabetes, liver disease, kidney disease, thyroid disorder, muscle disorder, history of malaria,tuberculosis, osteoporosis, glaucoma or cataracts.
- Self-reported adverse reactions to steroids
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制
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实验性的：地塞米松
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After six (6) hours of the accident, subject will take 5 mg of DEX in the Emergency Department (ED).
Within twenty-four (24) hours, the subjects will send in a saliva sample.
After sexen (7) days, subjects will participate in a phone interview.
After thirty (30) days, subjects will participate in an online assessment and return for a one month follow-up visit.
Subjects will then participate in online assessments at months 3,6,9, and 12 months.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in score on PTSD symptom severity measured with the PTSD Check-List 5 (PCL-5)
大体时间：1 month, 3 months, 6 months, 9 months, and 12 months
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Mean symptom severity on the PCL-5 will be compared between groups using an independent samples T-test.
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1 month, 3 months, 6 months, 9 months, and 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cortisol Levels measured from saliva samples
大体时间：24 hours post ED departure
|
24 hours post ED departure
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Score on Subjective Units of Distress (SUDS)
大体时间：1 month, 3 months, 6 months, 9 months, and 12 months
|
Scale of 0 to 10 for measuring the subjective intensity of disturbance or distress currently experienced by an individual.
The individual self assesses where they are on the scale.
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1 month, 3 months, 6 months, 9 months, and 12 months
|
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Score on the Kessler 6 Scale
大体时间：1 month, 3 months, 6 months, 9 months, and 12 months
|
Measure of Psychological distress in the anxiety-depression spectrum
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1 month, 3 months, 6 months, 9 months, and 12 months
|
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Score on Life Satisfaction Scale
大体时间：1 month, 3 months, 6 months, 9 months, and 12 months
|
The Satisfaction with Life Scale to assess satisfaction with people's lives as a whole.
The scale does not assess satisfaction with specific life domains, such as health or finances, but allows subjects to integrate and weigh these domains in whatever way they choose.
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1 month, 3 months, 6 months, 9 months, and 12 months
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Score on Center for Epidemiologic Studies Depression Scale (CES-D)
大体时间：1 month, 3 months, 6 months, 9 months, and 12 months
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1 month, 3 months, 6 months, 9 months, and 12 months
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Score on Perceived Ability to Cope with Trauma Scale (PACT)
大体时间：1 month, 3 months, 6 months, 9 months, and 12 months
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1 month, 3 months, 6 months, 9 months, and 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Isaac Galatzer-Levy, MD、NYU Langone Health
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年1月1日
初级完成 (实际的)
2017年12月12日
研究完成 (实际的)
2017年12月12日
研究注册日期
首次提交
2016年4月26日
首先提交符合 QC 标准的
2016年4月26日
首次发布 (估计)
2016年4月27日
研究记录更新
最后更新发布 (实际的)
2017年12月14日
上次提交的符合 QC 标准的更新
2017年12月12日
最后验证
2017年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.