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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：
9701841
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：
2017
资助国家：
美国
起止时间：
2017-07-01 至 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9701841
关键词：
Adverse effects Affect Affect Age Age Alcohol consumption Alcohol consumption Antidepressive Agents Antidepressive Agents Antipsychotic Agents Antipsychotic Agents Antisocial Personality Disorder Antisocial Personality Disorder Area Area Bipolar Disorder Bipolar Disorder Businesses Businesses Cannabis Cannabis Cardiovascular Diseases Cardiovascular Diseases Caring Caring Characteristics Characteristics Clinical Clinical Complement Complement Complex Complex Consent Consent DSM-V DSM-V Data Sources Data Sources Depressed mood Depressed mood Development Development Diagnosis Diagnosis Disease Disease Disease remission Disease remission Drug Use Disorder Drug Use Disorder Early Diagnosis Early Diagnosis Early treatment Early treatment Eating Disorders Eating Disorders Economics Economics Effectiveness Effectiveness Ensure Ensure Epidemiology Epidemiology Ethics Ethics Exclusion Criteria Exclusion Criteria Future Future Genetic Markers Genetic Markers Genetic Variation Genetic Variation Genetic screening method Genomics Genomics Health Health Healthcare Healthcare Healthcare Systems Healthcare Systems Hospitalization Hospitalization Informed Consent Informed Consent Inpatients Inpatients Insurance Carriers Insurance Carriers Intervention Intervention Major Depressive Disorder Major Depressive Disorder Measures Measures Medical Medical Medicine Medicine Mental Depression Mental Depression Mental Health Mental Health Mental disorders Mental disorders Metabolism Metabolism Methods Methods Military Personnel Military Personnel Modeling Modeling Nicotine Nicotine Obesity Obesity Outpatients Outpatients Patient Care Patient Care Patient-Focused Outcomes Patient-Focused Outcomes Patients Patients Pharmaceutical Preparations Pharmaceutical Preparations Pharmacogenetics Pharmacogenetics Post-Traumatic Stress Disorders Post-Traumatic Stress Disorders Process Process Provider Provider Psychiatry Psychiatry Psychotherapy Psychotherapy Questionnaires Questionnaires Randomized Randomized Randomized Clinical Trials Randomized Clinical Trials Recommendation Recommendation Research Research Schizophrenia Schizophrenia Services Services Severities Severities Site Site Test Result Test Result Testing Testing Time Time Tobacco use Tobacco use United States United States United States Centers for Medicare and Medicaid Services United States Centers for Medicare and Medicaid Services Validation Validation Variant Variant Veterans Veterans Visit Visit Work Work adherence rate alcohol use disorder alcohol use disorder base base care costs care costs clinical application clinical application clinical care clinical care combat combat commercialization commercialization cost cost depressive symptoms depressive symptoms dosage dosage experience experience functional disability functional disability functional improvement functional improvement genetic testing group intervention group intervention health administration health administration improved improved inclusion criteria inclusion criteria indexing indexing knowledge translation knowledge translation mortality mortality novel marker novel marker personalized cancer therapy personalized cancer therapy personalized medicine personalized medicine pharmacogenetic testing pharmacogenetic testing precision medicine precision medicine pressure pressure programs programs routine care routine care secondary outcome secondary outcome shared decision making shared decision making side effect suicidal risk suicidal risk treatment adherence treatment adherence treatment as usual treatment as usual treatment response 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：在过去的几年里，精神药物的商业药物遗传学（PGx）测试药物治疗作为实施“精准医疗”的一种手段已变得普遍，一些保险公司选择支付测试费用。这些事态发展给退伍军人带来了越来越大的压力卫生署实施以心理健康为重点的 PGxs 计划，特别是治疗抑郁症，但缺乏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来评估 PGx 测试在治疗重度抑郁症中的效用抑郁症。方法：多中心、随机临床试验（n=2000）。患者/提供者二元组将被随机分配给随机分组后（即干预组）或 6 个月后立即收到 PGx 电池的结果照常治疗（即延迟结果组）。该研究将检验以下假设： 1. 患有 MDD 的退伍军人，其护理以 PGx 电池结果为指导，将有更高的康复率根据患者健康调查问卷的测量，与延迟结果组相比，病情得到缓解 – 9 (PHQ-9) 分数 <5。 2. 接收 PGx 电池结果的提供者/患者二人组（即干预组）将使用与延迟结果组中的二人组相比，测试禁忌的药物更少。将使用以下受试者纳入和排除标准：纳入标准。 a) 年龄 18 岁至 80 岁（含）； b) PHQ-9 评分 >10 且推定诊断根据 PHQ9 标准的 MDD； c) 至少接受过一次 MDD 治疗（心理治疗或抗抑郁药）； d) 打算开始用抗抑郁药治疗重度抑郁症，并且 e) 愿意提供签署参与研究的知情同意书。排除标准。 a) 目前患有严重的并发精神疾病（即精神分裂症、双向情感障碍）障碍、精神病性重度抑郁症、边缘性或反社会人格障碍、饮食失调； b) 当前 DSM-5 诊断中度或重度酒精使用障碍； c) 目前 DSM-5 对药物使用障碍的诊断（尼古丁或大麻除外）； d) PTSD检查表（PCL-5）得分> 39； e) 目前正在使用抗精神病药物药物; f) 增强疗法，例如当时服用一种或多种抗抑郁药的现有处方随机化，不包括当前研究规定的抗抑郁药指标；曲扎酮剂量低于 150 毫克/天将不被视为增量； f) 住院时同意。对退伍军人医疗保健的预期影响：尽管流行病学上的迫切需要，抑郁症的治疗往往不够充分。正如现在多项研究所示，要实现缓解对于抑郁症，患者和提供者必须坚持不懈，尝试多种治疗方法，直到找到一种既有效又有效的治疗方法。可以忍受且有效。然而，每轮治疗都会带来更大的治疗损耗。迄今为止已进行的有限 PGx 实施研究的结果的复制可以开创MDD治疗新时代，为早期诊断和治疗提供动力，更快、更高的缓解率。