Developing Blood Tests for Mood Disorders

描述（由申请人提供） 翻译后摘要：迄今为止，没有临床实验室血液检测情绪障碍。鉴于情绪障碍的复杂性质，目前依赖于患者自我报告的症状和临床医生对患者访谈的印象，这是用现有治疗方式提供最佳护理以及开发新的和改进的治疗方法（包括新药物）的速度限制步骤。我们已经为帮助识别情绪障碍的血液生物标志物的方法提供了原理证明（Le-Niculescu et al. 2009）。这样的生物标志物可以作为客观的临床实验室测试的基础。我们鉴定候选生物标志物的方法是基于在人类受试者和动物模型中整合遗传和基因表达研究。在该领域的试点研究中，最近公布了1（Le-Niculescu等，2009），我们已经鉴定了一系列高概率的情绪状态血液候选生物标志物基因，值得将来仔细研究。基于一组10个顶级候选生物标志物（5个用于高情绪，5个用于低情绪）开发的预测评分在两个独立的患者队列中显示了高情绪（躁狂）和低情绪（抑郁）状态的灵敏度和特异性。我们的初步研究表明，血液生物标志物可能为大脑功能和疾病状态提供意想不到的信息窗口。这项高风险、高回报的工作需要扩展和完善，这也是我们建议要做的。抑郁症和双相情感障碍等情绪障碍的临床实验室血液检测的发展将对患者的健康，福祉，生活质量和独立功能产生影响，并减少住院和整体医疗保健费用。鉴于美国每五个人中就有一个人在一生中会患上严重的情绪障碍，这种工作的潜在医疗、社会和经济影响怎么强调都不为过。 公共卫生相关性：迄今为止，尚无精神疾病的客观临床实验室检查。目前依赖于不精确的诊断分类、患者自我报告的症状和临床医生的印象，导致对这些流行的、令人痛苦的和致残的病症的诊断和治疗不太理想。此外，缺乏客观的诊断测试是开发新药物和治疗方法的一个重大障碍。我们的工作旨在为这些问题提供解决方案。

DESCRIPTION (Provided by the applicant) Abstract: There are to date no clinical laboratory blood tests for mood disorders. Given the complex nature of mood disorders, the current reliance on patient self-report of symptoms and the clinician's impression on interview of patient is a rate limiting step in delivering the best possible care with existing treatment modalities, as well as in developing new and improved treatment approaches, including new medications. We have provided proof of principle for an approach to help identify blood biomarkers for mood disorders (Le-Niculescu et al. 2009). Such biomarkers can serve as a basis for objective clinical laboratory tests. Our approach to identifying candidate biomarkers is based on the integration of genetic and gene expression studies, in human subjects and animal models. In pilot studies in this area, recently published1 (Le- Niculescu et al. 2009) we have identified a series of high probability blood candidate biomarker genes for mood state that deserve future scrutiny. A predictive score developed based on a panel of ten top candidate biomarkers (five for high mood, five for low mood) shows sensitivity and specificity for high mood (mania) and low mood (depression) states, in two independent patient cohorts. Our preliminary studies suggest that blood biomarkers may offer an unexpectedly informative window into brain functioning and disease state. This high-risk, high reward work needs to be extended and refined, which is what we propose to do. The development of clinical laboratory blood tests for mood disorders such as depression and bipolar disorder will have an impact on patient health, well-being, quality of life, and independent functioning, as well as decrease hospitalizations and overall health-care costs. Given the fact that 1 in 5 people in the US will suffer from a major mood disorder in their lifetime, the potential medical, social and economic impact of such work cannot be overstated. Public Health Relevance: No objective clinical laboratory tests for psychiatric disorders exist to date. The current reliance on imprecise diagnostic classifications, on the patient's self-report of symptoms and the clinicians impression, leads to less than optimal diagnosis and treatment of these prevalent, distressing and disabling conditions. Moreover, the lack of objective diagnostic tests constitutes a significant barrier to the development of new medications and treatment approaches. Our work aims to provide solutions to these problems.