PRIME Care (PRecision medicine In MEntal health Care)

PRIME Care（精神卫生保健中的精密医学）

基本信息

批准号：
10208963
负责人：
DAVID W. OSLIN
金额：
--
依托单位：
PHILADELPHIA VA MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-07-01 至 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10208963
关键词：
Affect Age Alcohol consumption Antidepressive Agents Antipsychotic Agents Antisocial Personality Disorder Area Bipolar Disorder Businesses Cannabis Cardiovascular Diseases Caring Characteristics Clinical Complement Complex Consent DSM-V Data Sources Depressed mood Development Diagnosis Disease Disease remission Drug Use Disorder Early Diagnosis Early treatment Eating Disorders Economics Effectiveness Ensure Epidemiology Ethics Exclusion Criteria Future Genetic Markers Genetic Variation Genomics Health Healthcare Healthcare Systems Hospitalization Informed Consent Inpatients Insurance Carriers Intervention Major Depressive Disorder Measures Medical Medicine Mental Depression Mental Health Mental disorders Metabolism Methods Modeling Nicotine Obesity Outpatients Patient Care Patient-Focused Outcomes Patients Pharmaceutical Preparations Pharmacogenetics Post-Traumatic Stress Disorders Process Provider Psychiatry Psychotherapy Questionnaires Randomized Randomized Clinical Trials Recommendation Research Schizophrenia Severities Site Test Result Testing Time Tobacco use United States United States Centers for Medicare and Medicaid Services Validation Variant Veterans Veterans Health Administration Visit Work adherence rate alcohol use disorder base care costs clinical application clinical care combat commercialization cost depressive symptoms dosage experience functional disability functional improvement genetic testing group intervention implementation study improved inclusion criteria indexing knowledge translation military service mortality novel marker personalized cancer therapy personalized medicine pharmacogenetic testing precision medicine pressure programs routine care secondary outcome shared decision making side effect suicidal risk treatment adherence treatment as usual treatment response

项目摘要

Background: In the last several years, commercial pharmacogenetic (PGx) testing for psychotropic medications has become widespread as a means of implementing “precision medicine”, with some insurers electing to cover the cost of testing. These developments have put increasing pressure on the Veterans Health Administration to implement a mental health focused PGxs program, especially for treating depression, but without sufficient scientific study to support the utility of clinical application. Objectives: We propose a program of research to evaluate the utility of PGx testing in treating Major Depressive Disorder. Methods: Multi-site, randomized clinical trial (n=2000). Patient/provider dyads will be randomly assigned to receive the results of PGx battery either right after randomization (i.e. intervention group) or after 6 months of treatment as usual (i.e. delayed results group). The study will test the following hypotheses: 1. Veterans with MDD whose care is guided by the results of the PGx battery will have a higher rate of remission than those in the delayed results group, as measured by a Patient Health Questionnaire–9 (PHQ-9) score <5. 2. Provider/patient dyads that receive the results of the PGx battery (i.e., the intervention group) will use fewer medications contraindicated by the testing than dyads in the delayed results group. The following subject inclusion and exclusion criteria will be used: Inclusion Criteria. a) age 18 to 80 years, inclusive; b) PHQ-9 score of >10 and a presumptive diagnosis of MDD per PHQ9 criteria; c) at least one prior treatment exposure for MDD (psychotherapy or antidepressant); d) intent to start treatment of the MDD with an antidepressant, and e) willing to provide signed, informed consent to participate in the study. Exclusion Criteria. a) current serious co-occurring psychiatric illness (i.e., schizophrenia, bipolar disorder, psychotic major depression, borderline or antisocial personality disorder, eating disorder; b) current DSM-5 diagnosis of moderate or severe alcohol use disorder; c) current DSM-5 diagnosis of drug use disorder (other than nicotine or cannabis); d) PTSD checklist (PCL-5) score > 39; e) current use of an antipsychotic medication; f) augmentation therapy, e.g., an existing prescription of one or more antidepressants at the time of randomization, exclusive of the index antidepressant prescribed for the current study; trazadone at a dosage of less than 150 mg/day will not be considered augmentation; and f) inpatient hospitalization at the time of consent. Anticipated Impact on Veteran's Healthcare: Despite such a compelling epidemiological imperative, the treatment of depression is often inadequate. As shown now in several studies, to achieve remission from depression, patients and providers must be persistent and try multiple treatments until they find one that is both tolerable and effective. However, with each round of treatment, there is greater attrition from treatment. Replication of the results from the limited PGx implementation studies that have been conducted to date could usher in a new era in the treatment of MDD and provide an impetus for early diagnosis and treatment, resulting in more rapid and higher rates of remission.

背景：在过去的几年中，精神植物的商业药物遗传学（PGX）测试作为实施“精确医学”的一种手段，药物已变得普遍，并提供了一些确保选择支付测试成本。这些事态发展给退伍军人带来了越来越大的压力卫生管理局实施以心理健康为中心的PGXS计划，尤其是用于治疗抑郁症，但是没有足够的科学研究来支持临床应用的效用。目标：我们提出了一项研究计划，以评估PGX测试的实用性抑郁症。方法：多部位，随机临床试验（n = 2000）。患者/提供者二元组将随机分配给随机化后立即接收PGX电池的结果（即干预组）或6个月后照常治疗（即延迟结果组）。该研究将检验以下假设： 1。与MDD的退伍军人，其护理受PGX电池的结果指导缓解比延迟结果组中的缓解，如患者健康问卷– 9 （PHQ-9）得分<5。 2。接收PGX电池结果（即干预组）的提供者/患者二元组将使用在延迟结果组中，测试禁用的药物较少。将使用以下主题包含和排除标准：纳入标准。 a）18至80岁，包括； b）PHQ-9得分> 10和一个假定的诊断根据PHQ9标准的MDD； c）至少一次先前一次接受MDD治疗（心理治疗或抗抑郁剂）； d）打算用抗抑郁药开始对MDD进行治疗，e）愿意提供签署，知情同意参加该研究。排除标准。 a）当前严重的同时发生精神病（即精神分裂症，双极障碍，精神病性抑郁症，边缘或反社会人格障碍，饮食失调； b）电流 DSM-5中度或重度饮酒障碍的诊断； c）当前的DSM-5药物使用障碍诊断（尼古丁或大麻除外）； D）PTSD清单（PCL-5）得分> 39; e）当前使用抗精神病药物药物; f）增强疗法，例如，当时的一种或多种抗抑郁药的现有处方随机化，不包括针对本研究的指数抗抑郁药；剂量的Trazadone 少于150毫克/天的人将不被视为增强； f）住院治疗同意。对退伍军人的医疗保健的预期影响：尽管如此引人注目的流行病学势在必行，但抑郁症的治疗通常不足。如今在几项研究中所示，以从抑郁症，患者和提供者必须保持持久性并尝试多种治疗，直到发现两者都是可容忍有效。但是，在每一轮治疗中，治疗都会增加。迄今已进行的有限PGX实施研究的结果复制可以在MDD的治疗中迎来了一个新时代，并为早期诊断和治疗提供了动力在更快和更高的缓解速度下。