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临床试验/NCT01153529
NCT01153529已完成不适用

CSP #575 - Post-Deployment Afghanistan/Iraq Trauma Related Inventory of Traits (PATRIOT): Phase 1 (Feasibility Study)

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
Response Rate

研究概览

简要总结

The long-term goal of this research project is to identify genes that contribute to or guard against developing posttraumatic stress disorder (PTSD) and to better understand how genes and life experiences work together to impact PTSD. Inherited traits are passed down from one generation to the next in genes. Genes contain molecules called DNA, which contain the information that determines our characteristics and carries instructions for constructing and operating our body. Most human diseases have an inherited element. In addition, we, the investigators, hope to learn about how genes and the other materials we find in participants' blood relate to other illnesses and behaviors.

The goal of the feasibility project covered by this application is to test the possibility of conducting research on a large number of veterans in order to look at the association between genes and PTSD. We are inviting 1,000 OEF/OIF veterans to participate, of these, we are anticipating approximately 250 veterans who have served in Afghanistan and/or Iraq to participate in this study. Although 250 participants is our target enrollment, we plan to enroll all veterans included in our initial mailings who desire to participate. We do not anticipate this to exceed 500 individuals. This phase of the study is expected to last about one year. Specific aims are: 1. evaluation of sampling methods and participation rates; 2. field testing of assessment batteries including reliability and validity; and 3. evaluation of the proposed DNA collection and storage procedures.

详细描述

PURPOSE:

The primary purpose of this feasibility project is to evaluate the feasibility of collecting a case-control cohort of OEF/OIF veterans that is large enough to make possible the identification of genetic variants that affect the risk for PTSD after exposure to traumatic events.

We will also determine if the DNA samples will be of sufficient quality for subsequent analyses.

The primary purpose of the main project which is not covered by this application is to identify genes that affect the risk of developing PTSD.

  • RESEARCH QUESTIONS:

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 1.Participant must have served in support of Operation Enduring Freedom or Operation Iraqi Freedom (OEF/OIF) as this is a study relevant to these veterans

排除标准

  • Participants who were unconscious for more than 30 minutes. This may impact event recall
  • Lifetime diagnosis and/or treatment of bipolar disorder or schizophrenia. (NOTE: PTSD in the context of these severe psychiatric disorders is likely to be different from PTSD outside of that context. Excluding subjects with severe psychiatric disorders will increase the homogeneity of the sample and our power to detect genetic effects.)
  • Refusal to participate.

结局指标

主要结局

Response Rate

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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