CSP #575B - Genomics of Posttraumatic Stress Disorder Among Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- PTSD diagnosis
研究概览
简要总结
Posttraumatic Stress Disorder (PTSD), as a common and serious mental health condition, affects about 25% of all military personnel that have served in combat. People suffering from PTSD may experience traumatic flashbacks, trouble sleeping, and problems in their relationships. This study is intended to help identify genes that influence and increase the risk of PTSD, to improve ways of detecting and treating the condition in the future.
Previous research has studied genes that increase the risk of PTSD, but none of these have included a Veteran-only population. The current study focuses on US Veterans, utilizing the VA Million Veteran Program (MVP) database of approximately 300,000 participants as of August 2014. In this context, participants with PTSD are referred to as "cases" and Veterans without PTSD are referred to as "controls."
This project will be done in three stages. The first stage will look at MVP-obtained data and electronic health record (EHR) data to implement methods for identifying combat-exposed case patients with PTSD and combat-exposed control patients without PTSD. The second stage will assemble and validate a study population of 20,000 participants "including 10,000 combat-exposed Veterans with PTSD as cases and 10,000 combat-exposed Veterans without PTSD as controls. The third stage will conduct genetic analyses ("genotyping") comparing the cases to controls, to identify genes associated with increased risk of developing the condition.
详细描述
Background and Objectives
Posttraumatic stress disorder (PTSD) is a severe, sometimes disabling, anxiety disorder that can develop after a potentially traumatic event involving actual or threatened death, serious injury, or sexual violation. The diagnosis of PTSD requires symptoms for at least one month from three categories: re-experiencing, avoidance, and increased arousal. In contrast to an acute response to trauma, the stress reactions of persons who develop PTSD do not resolve quickly; symptoms can last for long periods of time and may increase in severity.
The rate of PTSD (and consequent disability) is especially high among combat-exposed military Veterans. Studies of Vietnam combat veterans have consistently found a lifetime PTSD prevalence of 25-30% of men, although rates of persistent/chronic PTSD have been somewhat lower (15-20%). Studies of OEF/OIF Army personnel have reported rates of PTSD in the 10% to 15% range following deployment (Thomas et al 2010). These rates are much higher than the rate of PTSD in the general US population, estimated to be about 6.8% (Kessler et al 2005).
PTSD has been shown to be influenced genetically, and previous work has identified several possible genes that increase the risk of PTSD. Although several genomewide association studies (GWASs) have been conducted, the corresponding statistical power has been modest, and none included a Veteran-only population. The proposed study will address those deficiencies by conducting a well-powered case-control GWAS study in a large sample of US Veterans with PTSD as "cases" and psychiatrically-healthy Veterans as "controls."
Preliminary Data and Research Design
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Combat-exposed Veterans who participated in the Million Veteran Program.
排除标准
- •schizophrenia
- •bipolar disorder
结局指标
主要结局
PTSD diagnosis
时间窗: 2 years
The study will use a case-control design nested within the VA Million Veteran Program (MVP), with genotype as the exposure variable and PTSD diagnosis (yes/no) as the outcome variable.
次要结局
未报告次要终点