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: 7163109
• 负责人: MARCIA VALENSTEIN
• 金额: $ 35.69万
• 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/7163109
• 关键词: antidepressants; clinical depression; clinical research; disease /disorder proneness /risk; health care service utilization; human data; human therapy evaluation; information systems; longitudinal human study; outcomes research; patient /disease registry; serotonin inhibitor; statistics /biometry; suicide; therapy adverse effect; time resolved data

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）：虽然抗抑郁药物在减少成年人的抑郁症状方面是有效的，但最近再次出现的担忧是，这些药物可能会增加治疗开始或剂量变化期间的自杀风险。FDA已经发布了儿童和青少年使用抗抑郁药的“黑匣子”警告，并建议在开始或改变剂量时密切监测所有年龄段的患者。目前FDA的警告是基于自杀行为，而不是自杀未遂。然而，这些中间结果往往很难分类，可能与自杀完成没有完全的连续性。社区治疗的结果也可能与对照试验的结果不同，在对照试验中，预防性药物的使用受到严格限制。我们将使用VA国家抑郁症登记处（NARDEP），医疗保险和国家死亡指数数据来检查抗抑郁药，伴随治疗和自杀完成之间的关系。NARDEP包括从1997财政年度（FY）起超过1，500，000名被诊断患有抑郁症的患者的纵向数据，包括人口统计学数据，卫生服务使用（从FY97起）和药房使用（从FY99起）。大约994，000人将符合拟议研究的入选标准，数据超过2，800，000人年。我们将评估接受以下治疗的患者自杀率和自杀未遂率的潜在差异：a）用不同的抗抑郁药物组治疗，B）用SSRI类中四种最常用的处方药和SSRI药物的三种最常用的处方药替代物治疗，c）与抗抑郁药一起使用以增强治疗反应的促效剂，和d）与抗抑郁药一起使用以解决失眠的补充催眠剂。研究分析将首先使用具有随时间变化的治疗暴露和协变量的Cox比例风险模型。我们还将使用具有治疗加权逆概率（IPTW）和工具变量的考克斯模型来解决潜在的治疗选择偏倚。除了主要队列分析外，我们还将使用病历数据进行两项巢式病例对照研究，以详细评估管理数据中无法观察到的潜在选择偏倚。这些子研究将为队列分析提供信息，并使我们能够适当地解释研究结果。临床医生、政策制定者和患者迫切需要更多关于替代抑郁症治疗在减少自杀方面的相对有效性的信息。我们预计，拟议的项目将推进这一关键领域的知识，并为未来使用组织数据集来检查自杀等哨兵事件的努力提供信息。