Risks and Benefits of ADHD Medication for Psychiatric and Neurologic Problems

ADHD 药物治疗精神和神经系统问题的风险和益处

• 批准号: 8880288
• 负责人: Brian M D'Onofrio
• 金额: $ 40.9万
• 依托单位: TRUSTEES OF INDIANA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8880288
• 关键词: Accounting; Adverse effects; Alcohol or Other Drugs use; Attention deficit hyperactivity disorder; Benefits and Risks; Bipolar Disorder; Data Set; Diagnosis; Epidemiologic Studies; Epidemiology; Epilepsy; Etiology; Experimental Designs; Foundations; Goals; Health; Heterogeneity; Hyperactive behavior; Impulsivity; Individual; Insurance; International; Intervention Studies; Long-Term Effects; Longitudinal Studies; Major Depressive Disorder; Manic; Medical; Minor; Motor Vehicles; Neurologic; Neurological outcome; Observational Study; Outcome; Patients; Pharmaceutical Preparations; Population; Randomized; Randomized Controlled Trials; Research; Research Personnel; Risk; Risk Estimate; Sampling; Seizures; Specific qualifier value; Substance abuse problem; Sweden; Symptoms; Techniques; Testing; Time; Translating; Translational Research; Uncertainty; United States; Work; adverse outcome; base; cohort; design; developmental disease; follow-up; functional outcomes; inattention; indexing; innovation; insight; population based; prospective; research study; response; suicidal behavior; treatment response

DESCRIPTION (provided by applicant): Randomized controlled trials suggest that ADHD medication has beneficial short-term effects. The increasing use of ADHD medications is being heavily debated, however, because of concerns regarding the short- and long-term effects of ADHD medications. The overall objective for this proposal is to more precisely estimate the magnitude of the short- and long-term risks and benefits of ADHD medications on serious psychiatric (substance abuse, suicidal behavior, mania/bipolar disorder, and major depression) and neurological (seizures/epilepsy) outcomes by conducting advanced pharmaco-epidemiologic analyses in two large datasets that include prospective longitudinal information on prescribed ADHD medications and medical problems. We will use a Swedish cohort of 75,000 patients with a diagnosis of ADHD based on national registers. And, we will conduct analyses on a large US sample based on insurance claims, including 2.3 million patients with ADHD. The analyses in both datasets will use the same analytical approaches, including within-individual comparisons and advanced statistical techniques to account for stable and time-varying confounding. Our central hypothesis is that ADHD medication will be associated with reduced psychiatric and neurological problems and that risk for adverse outcomes (e.g., short-term seizures and long-term substance use problems) will be minor, especially when we compare the relations within individuals. The first aim is to examine the short-term effects of ADHD medications on these problems. The second aim is to examine the long-term effects of ADHD medications on these problems. The rationale for the proposed research is that rigorous pharmaco-epidemiologic studies-employing advanced designs and statistical analyses with large, population samples-can more precisely characterize the risks and benefits of ADHD medication. The significance of the proposed research is that the results will more precisely identify the specific risks and benefits associated with ADHD medication, which previous studies have been unable to adequately explore. The proposed analyses, which are based on the two large datasets, also will explore the generalizability of the findings across different national, cultural, and medical contexts. These efforts would directly inform medical practice and influence subsequent research in numerous fields, such as pharmaco-epidemiology and randomized controlled trials. The proposed research is innovative because the research team will analyze two datasets (in Sweden and the United States); combine within-individual comparisons with sophisticated analytical strategies to rule out confounding factors; and bring together a team of international researchers with expertise in the etiology and treatment of ADHD, pharmaco-epidemiology, quasi-experimental designs, and analyses of both datasets. We propose, therefore, to conduct the most comprehensive study of serious psychiatric and neurologic problems associated with ADHD medication to date.

描述（由申请人提供）：随机对照试验表明多动症药物具有有益的短期效果。然而，由于人们担心多动症药物的短期和长期影响，越来越多地使用多动症药物引起了激烈的争论。该提案的总体目标是更准确地估计 ADHD 药物对严重精神疾病（药物滥用、自杀行为、躁狂/双相情感障碍和重度抑郁）和神经疾病（癫痫发作）的短期和长期风险和益处的程度。 /癫痫）结果，通过在两个大型数据集中进行高级药物流行病学分析，其中包括有关多动症处方药物和医疗问题的前瞻性纵向信息。我们将使用由 75,000 名瑞典患者组成的队列，这些患者根据国家登记册被诊断为 ADHD。而且，我们将对基于保险索赔的美国大型样本进行分析，其中包括 230 万多动症患者。两个数据集中的分析将使用相同的分析方法，包括个体内比较和先进的统计技术，以解释稳定和随时间变化的混杂因素。我们的中心假设是，多动症药物将与减少精神和神经问题相关，并且不良后果（例如短期癫痫发作和长期药物使用问题）的风险很小，特别是当我们比较个体内部的关系时。第一个目标是检查多动症药物对这些问题的短期影响。第二个目标是检查多动症药物对这些问题的长期影响。拟议研究的基本原理是，严格的药物流行病学研究——采用先进的设计和对大量人群样本进行统计分析——可以更准确地描述多动症药物的风险和益处。拟议研究的意义在于，结果将更准确地确定与多动症药物相关的特定风险和益处，而先前的研究无法充分探讨这一点。拟议的分析基于两个大型数据集，还将探讨研究结果在不同国家、文化和医学背景下的普遍性。这些努力将直接为医疗实践提供信息，并影响许多领域的后续研究，例如药物流行病学和随机对照试验。拟议的研究具有创新性，因为研究团队将分析两个数据集（瑞典和美国）；将个体内比较与复杂的分析策略相结合，以排除混杂因素；并汇集了一支由在 ADHD 病因学和治疗、药物流行病学、准实验设计以及两个数据集分析方面具有专业知识的国际研究人员组成的团队。因此，我们建议对迄今为止与多动症药物相关的严重精神和神经问题进行最全面的研究。