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Risk Factors for Psychosis and Mania with Prescription Amphetamine Use

使用处方安非他明导致精神病和躁狂症的危险因素

基本信息

批准号：
10612085
负责人：
LAUREN V MORAN
金额：
$ 69.41万
依托单位：
MCLEAN HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-06-10 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10612085
关键词：
Acceleration Address Admission activity Adolescent Adolescent and Young Adult Adult Affective Age Amphetamine Users Amphetamines Antipsychotic Agents Area Attention deficit hyperactivity disorder Big Data Bipolar Disorder Boston Case/Control Studies Child Clinical Clinical Data Clinical Practice Guideline Clinical Practice Patterns Cohort Studies Complement Computerized Medical Record Data Data Set Data Sources Databases Diagnosis Disease Dose Ethnic Origin Family Family history of First Degree Relative Future Goals Healthcare Hospitalization Hospitals Immigration Interdisciplinary Study Intervention Journals Knowledge Label Manic Measurement Medicine Mental disorders Modification Mood stabilizers National Institute of Mental Health Natural Language Processing New England Outcome Patients Pattern Pharmaceutical Preparations Pharmacologic Substance Pharmacy facility Positioning Attribute Practice Guidelines Prevention Principal Investigator Provider Psychiatric Hospitals Psychoses Public Health Publishing Race Recording of previous events Relative Risks Reporting Research Research Design Risk Risk Factors Ritalin Sampling Socioeconomic Status Stimulant Symptoms Testing Translating Woman adverse outcome amphetamine use base comorbidity comparative cost effective data warehouse first episode psychosis high risk innovation marijuana use patient subsets practice setting prescription stimulants prevent provider factors psychosis risk psychotic risk mitigation stimulant use treatment risk university student

项目摘要

ABSTRACT: The use of prescription amphetamines for the treatment of attention-deficit hyperactivity disorder (ADHD) has markedly increased in the last fifteen years, with the greatest increase in adolescents and young adults. In 2007, the FDA mandated changes to stimulant labels to warn of increases in psychosis and mania in patients without pre-existing conditions. Our multidisciplinary research team from Brigham and Women's Hospital and McLean Hospital recently published a landmark cohort study demonstrating an increased risk of psychotic episodes in new users of amphetamine compared to methylphenidate in adolescents and young adults with ADHD. Alarmingly, the use of amphetamines increased four-fold over the study period (2004 – 2015). In addition, our data show that prescription amphetamine use has dramatically increased in patients with pre-existing bipolar disorder. Thus, there is an urgent need to accelerate knowledge about prescriber-level factors, patient-level factors and disease states that potentiate the risk of psychosis and mania with prescription amphetamines. Large-scale studies using real-world data are the only option to study the risk of infrequent and serious adverse outcomes. In Aim 1, using incident-user cohort study designs, we will utilize data from two national administrative claims databases to identify prescriber dosing strategies that increase the risk of first-episode psychosis in ~220,000 adolescents and adults with ADHD initiating amphetamines. We hypothesize that there will be a dose-dependent increase in the risk of psychosis. The goal of Aim 2 is to identify patient subgroups at heightened risk of psychosis/mania with prescription amphetamine use. To accomplish this goal, we will perform a case control study using electronic medical records (EMR) from McLean Hospital in ~1,650 patients hospitalized for an initial episode of psychosis or mania compared to ~3,300 controls with a first psychiatric hospitalization for reasons other than psychosis or mania. We will apply natural language processing to unstructured narrative notes to capture detailed patient data not available in claims data. We hypothesize that patients with a family history of psychiatric illness will have an increased risk of psychosis/mania with amphetamines compared to patients without a family history. We also hypothesize that patients with concurrent cannabis use will have an increased risk of psychosis/mania with amphetamines compared to patients without cannabis use. Aim 3 compares the risk of treatment-emergent mania in ~52,000 new users of amphetamine versus methylphenidate in a cohort study of patients with pre-existing bipolar disorder, an urgent issue given the known risk of mania with stimulant use. Combined, these studies will provide actionable evidence to be incorporated into clinical practice guidelines with the goal of mitigating the risk of psychosis and mania with prescription stimulants. The proposed research agenda aligns with NIMH Strategic Objective 3.3 “Striving for Prevention and Cure” on testing interventions in real-world practice settings to evaluate the impact of patient- and provider-level factors on clinical outcomes.

摘要：使用处方安非他明治疗注意缺陷多动障碍在过去的15年里，ADHD的发病率明显增加，其中青少年和年轻人的增幅最大。成年人了2007年，FDA要求改变兴奋剂标签，以警告精神病和躁狂症的增加，无既往病史的患者。我们的多学科研究团队从布里格姆和妇女的医院和姆克林医院最近发表了一项具有里程碑意义的队列研究，表明青少年中安非他明与哌甲酯新使用者的精神病发作比较成人ADHD令人震惊的是，安非他明的使用在研究期间（2004年至2010年）增加了四倍。 2015年）的报告。此外，我们的数据显示，处方安非他明的使用在患者中急剧增加，有躁郁症的病人因此，迫切需要加快了解处方药水平因素，患者水平的因素和疾病状态，加强精神病和躁狂症的风险，处方安非他明使用真实世界数据的大规模研究是研究罕见和严重的不良后果。在目标1中，使用事件用户队列研究设计，我们将利用来自两个国家行政索赔数据库的数据，以确定增加在约220，000名患有ADHD的青少年和成人中首次发作精神病的风险开始使用安非他明。我们假设精神病的风险会有剂量依赖性的增加。目标2的目标是确定使用处方安非他明的精神病/躁狂症风险增高的患者亚组。到为了实现这一目标，我们将使用电子病历（EMR）进行病例对照研究，姆克林医院对约1，650名因精神病或躁狂症首次发作而住院的患者进行了研究，约3，300名对照者因精神病或躁狂症以外的原因首次精神病住院治疗。我们将应用对非结构化叙述性笔记进行自然语言处理，以捕获无法获得的详细患者数据索赔数据。我们假设有精神病家族史的患者，与无家族史的患者相比，安非他明导致的精神病/躁狂症的发生率。我们还假设同时使用大麻的患者使用安非他明会增加精神病/躁狂症的风险与不使用大麻的患者相比。目的3：比较约52，000名患者中治疗后出现躁狂的风险在既存双相情感障碍患者队列研究中，安非他明与哌甲酯的新使用者这是一个紧迫的问题，因为已知使用兴奋剂有躁狂的风险。结合起来，这些研究将提供可操作的证据，纳入临床实践指南，以减轻服用处方兴奋剂会导致精神病和躁狂症的风险。拟议的研究议程与NIMH保持一致战略目标3.3“致力于预防和治疗”，在实际实践环境中测试干预措施评估患者和提供者层面因素对临床结局的影响。