PRIME Care (PRecision medicine In MEntal health Care)

背景：在过去的几年里，精神药物的商业遗传药物(PGx)测试 药物治疗作为实施“精准医疗”的一种手段已经变得普遍，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 卫生署将实施以精神健康为重点的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实用性。 目的：我们提出了一项研究计划，以评估PGx检测在治疗重大疾病中的作用 抑郁障碍。 方法：多点随机临床试验(n=2000)。患者/提供者二人组将随机分配到 在随机分组(即干预组)之后或在6个月后收到PGx电池的结果 按常规治疗(即延迟结果组)。这项研究将检验以下假设： 1.患有MDD的退伍军人，如果他们的护理是以PGx电池的结果为指导的，那么他们将有更高的 通过患者健康问卷-9衡量，缓解率高于延迟结果组 (PHQ-9)分数&lt； 2.接受PGx电池结果的提供者/患者二人组(即，干预组)将使用 在延迟结果组中，测试中禁忌的药物比DYADS少。 将使用以下科目纳入和排除标准： 纳入标准。A)18至80岁，包括18至80岁；b)PHQ-9评分10和推定诊断 符合PHQ9标准的MDD；c)至少一次MDD既往治疗暴露(心理治疗或 抗抑郁剂)；d)打算开始使用抗抑郁剂治疗MDD，以及e)愿意提供 签署知情同意书，同意参与研究。 排除标准。A)目前严重的共生精神疾病(即精神分裂症、躁郁症 精神障碍、精神病性抑郁症、边缘或反社会人格障碍、进食障碍；b)当前 DSM-5诊断中重度酒精使用障碍；c)当前DSM-5对药物使用障碍的诊断 (尼古丁或大麻除外)；d)创伤后应激障碍检查表(PCL-5)评分；39；e)抗精神病药物的当前使用情况 药物治疗；f)强化疗法，例如，当时一种或多种抗抑郁药的现有处方 随机，不包括为本研究开出的指数抗抑郁药；曲扎酮的剂量 每天少于150毫克将不被视为增加；以及f)在下列情况下住院治疗 同意。 对退伍军人医疗保健的预期影响：尽管流行病学势在必行，但 抑郁症的治疗通常是不充分的。正如现在在几项研究中所表明的那样，要实现从 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，而且有效。然而，随着每一轮治疗的进行，治疗过程中会产生更大的损耗。 复制迄今已进行的有限的PGx实施研究的结果可能 开启MDD治疗的新纪元，为早期诊断和治疗提供动力，从而 在更快更高的缓解率中。

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.