Antidepressants, Concurrent Treatments, and Completed Suicide in VA Registry Data

VA 登记数据中的抗抑郁药、同步治疗和自杀完成情况

• 批准号: 7269771
• 负责人: MARCIA VALENSTEIN
• 金额: $ 40.19万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-01 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7269771
• 关键词: Address; Adjuvant Analgesic; Adolescent; Adult; Affect; Age; Alcohol or Other Drugs use; Amitriptyline; Antidepressive Agents; Antipsychotic Agents; Area; Benzodiazepines; Boxing; Bupropion; Caucasoid Race; Cessation of life; Child; Citalopram; Class; Cohort Analysis; Communities; Comorbidity; Condition; Country; Cox Models; Cox Proportional Hazards Models; Data; Data Set; Databases; Depressed mood; Depressive disorder; Diagnosis; Disease regression; Dose; Effectiveness; Epidemiologist; Ethnic Origin; Evaluation Research; Event; Fluoxetine; Future; Gender; Generations; Health Services; Health system; Healthcare Systems; Individual; Information Systems; Institute of Medicine (U.S.); Knowledge; Lithium; Medical; Medical Records; Medicare; Mental Depression; Meta-Analysis; Methodology; Methods; Minority; Mirtazapine; Modeling; Nested Case-Control Study; Observational Study; Outcome; Paroxetine; Patient Monitoring; Patients; Pattern; Persons; Pharmaceutical Preparations; Pharmaceutical Services; Pharmacy facility; Physicians; Population; Probability; Psychiatrist; Race; Randomized Controlled Trials; Rate; Registries; Relative (related person); Research; Research Personnel; Resources; Risk; Sample Size; Sampling; Score; Selection Bias; Selection for Treatments; Selective Serotonin Reuptake Inhibitor; Sentinel; Sertraline; Sleeplessness; Slow-Wave Sleep; Suicide; Suicide attempt; Supplementation; Symptoms; Time; Trazodone; Treatment outcome; United States Food and Drug Administration; Veterans; Vulnerable Populations; Weight; Woman; Work; Youth; Zaleplon; accomplished suicide; base; cohort; demographics; depressive symptoms; dosage; health organization; hypnotic; ideation; inclusion criteria; indexing; inhibitor/antagonist; innovation; male; men; multidisciplinary; older men; programs; response; reuptake; severe mental illness; sex; suicidal behavior; suicidal risk; suicide rate; tool; venlafaxine

DESCRIPTION (provided by applicant): Although antidepressant medications are effective in reducing depressive symptoms among adults, concerns recently have re-emerged that these medications may increase suicide risks during times of treatment initiation or dosage change. The FDA has issued a "black box" warning for antidepressants when used by children and adolescents and advised close monitoring of patients of all ages when beginning or changing doses. Current FDA warnings are based on suicidal behaviors rather than completed suicide. However, these intermediate outcomes are often difficult to categorize and may not be on a complete continuum with completed suicide. Outcomes of treatment in the community may also differ from outcomes in controlled trials in which the use of adjunctive medications are sharply limited. We will use the VA National Registry for Depression (NARDEP), Medicare, and National Death Index data to examine the relationships between antidepressants, concomitant treatments, and completed suicide. NARDEP includes longitudinal data for over 1,500,000 patients diagnosed with depression from fiscal year (FY) 1997 forward, including data on demographics, health services use (from FY97 forward), and pharmacy use (from FY99 forward). Approximately 994,000 individuals will meet inclusion criteria for the proposed study, with over 2,800,000 person-years of data. We will evaluate potential differences in rates of suicide and suicide attempts among patients receiving: a) treatment with different antidepressant medication groups, b) treatment with four most commonly prescribed agents within the SSRI class and the three most commonly prescribed alternatives to SSRI agents, c) adjunctive agents used with antidepressants to augment treatment response, and d) supplemental hypnotic agents used with antidepressants to address insomnia. Study analyses will first use Cox-proportional hazards models with time-varying treatment exposures and covariates. We will also use Cox models with inverse probability of treatment weighting (IPTW) and instrumental variables to address potential treatment selection biases. In addition to the primary cohort analyses, we will conduct two nested case-control studies, using medical record data, to conduct a detailed assessment of potential selection biases that are not observable in the administrative data. These sub- studies will inform the cohort analyses and allow us to appropriately interpret study results. Clinicians, policymakers, and patients urgently need additional information about relative effectiveness of alternative depression treatments in reducing suicide. We anticipate that the proposed project will advance knowledge in this critical area and inform future efforts to use organizational datasets to examine sentinel events, such as suicide.

描述（由申请人提供）：尽管抗抑郁药可有效减轻成年人的抑郁症状，但最近人们重新出现了这些药物在治疗开始或剂量变化期间可能会增加自杀风险。 FDA在儿童和青少年使用时向抗抑郁药发出了“黑匣子”警告，并建议在开始或改变剂量时对所有年龄段的患者进行密切监测。当前的FDA警告是基于自杀行为而不是完成自杀的。但是，这些中级结果通常很难分类，并且可能没有完整的自杀。社区中治疗结果也可能与对照试验的结果有所不同，在对照试验中，使用辅助药物的使用受到了极大的限制。我们将使用VA国家抑郁症（NARDEP），Medicare和国家死亡指数数据来检查抗抑郁药，伴随治疗方法和完成自杀之间的关系。 NARDEP包括1,500,000多名1997财政年度诊断患有抑郁症的患者的纵向数据，包括有关人口统计数据的数据，健康服务的使用数据（来自97财年的前进）和药房使用（来自99财年的Forward）。大约994,000个人将符合拟议研究的纳入标准，并拥有超过2,800,000人的数据。我们将评估接受的患者自杀率和自杀率的潜在差异：a）使用不同的抗抑郁药组治疗，b）用SSRI类中的四种最常见的处方药治疗，三种最常见的替代方案，以及SSRI代理的三种最常见的替代方案，c）与抗抗抑郁剂一起使用，以增强反应剂的辅助治疗，D） 失眠。研究分析将首先将COX-PROVATITARE危害模型与时变的治疗暴露和协变量一起使用。我们还将使用具有逆可能性加权（IPTW）和仪器变量逆概率的COX模型来解决潜在的治疗选择偏见。除了主要队列分析外，我们还将使用病历数据进行两项嵌套的病例对照研究，以详细评估潜在的选择偏见，而行政数据中无法观察到的偏见。这些子研究将为队列分析提供信息，并使我们能够适当解释研究结果。临床医生，政策制定者和患者急需有关替代性抑郁症治疗相对有效性减少自杀的相对有效性的其他信息。我们预计拟议的项目将促进在这个关键领域的知识，并为未来的努力提供使用组织数据集检查Sentinel事件的努力，例如自杀。