PRIME Care (PRecision Medicine In MEntal Health Care)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,944
- 试验地点
- 48
- 主要终点
- Depression Remission
研究概览
简要总结
The focus of this application is on the impact of providing depressed Veterans and their providers with the results of pharmacogenetic (PGx) testing for psychotropic medications. The project focuses on whether and how patients and providers use genetic test results given to them at the time an antidepressant is to be initiated to treat Major Depressive Disorder (MDD) and whether use of the test results improves patient outcomes. MDD is one of the most common conditions associated with military service and combat exposure, increases suicide risk, and worsens the course of common medical conditions, making it a leading cause of functional impairment and mortality. Validation of a PGx test to personalize the treatment of MDD represents an important opportunity to improve the healthcare of Veterans.
详细描述
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: The investigators propose a program of research to evaluate the utility of PGx testing in treating Major Depressive Disorder.
Methods: The investigators plan a multi-site RCT (n=2000), patient/provider dyads will be randomly assigned to receive results of the PGx battery 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:
- Veterans with MDD whose care is guided by the results of the PGx battery (the intervention group) will have a higher rate of remission of depression than the delayed results group. (Primary Hypothesis)
- Provider/patient dyads in the intervention group will use fewer medications that have potential gene-drug interactions based on commercial PGx test results than dyads in the delayed results group (Primary Hypothesis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •PHQ-9 score 10 and a presumptive diagnosis of MDD per PHQ-9 criteria
- •at least one prior treatment exposure for MDD (psychotherapy or antidepressant
- •intent to start treatment of the MDD with an antidepressant, simple dose increases will not be considered inclusionary
- •willingness to provide signed, informed consent to participate in the study
排除标准
- •current serious co-occurring psychiatric illness, i.e.:
- •schizophrenia
- •bipolar disorder
- •psychotic major depression
- •borderline or antisocial personality disorder
- •eating disorder
- •active alcohol or other drug use disorder
- •current use of an antipsychotic medication
- •augmentation therapy, e.g.:
- •use of two or more antidepressants at the time of randomization (trazodone at a dosage < 150 mg/day will not be considered augmentation and thus allowed)
- •patients requiring urgent care or inpatient hospitalization at the time of consent
- •currently incarcerated
结局指标
主要结局
Depression Remission
时间窗: 24 weeks post randomization
The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. Remission was defined as a score of 5 or less at the endpoint. the reported number of participants are those reaching that threshold of symptoms.
Use of Fewer Medications That Have Potential Gene-drug Interactions
时间窗: Over the first 30 days
The investigators will examine the proportion of antidepressants prescribed in the first 30 days of the trial that have the potential for gene-drug interactions. The chance for a gene-drug interaction was classified as 1. the subject did not have a prescription for an antidepressant during the initial 4 weeks of the trial (No Antidepressant), 2 the subject was prescribed an antidepressant with no known gene-drug interaction (No Gene Interaction), 3 the subject was prescribed an antidepressant with moderate gene-drug interactions (Moderate Interaction). These are also gene-drug interactions that do not have level A concordance. And 4. the subject was prescribed an antidepressant with substantial gene-drug interactions or gene-drug interactions that are considered to have a high level of evidence to support other prescribing.
次要结局
- Depression Response(24 weeks)
- Depression Severity(24 Weeks)