Antidepressant Use and Suicidality: Comparative Safety in Children and Adults

描述(申请人提供)：2004年10月，美国食品和药物管理局(FDA)发布了一项建议，称抗抑郁药物可能与儿童和青少年自杀想法和行为的风险增加有关。这些警告是因为它对这个年龄段所有可用的抗抑郁药物随机试验进行了荟萃分析，在这些试验中，随机服用抗抑郁药物的患者自杀意念或行为的比率几乎是服用安慰剂的患者的两倍。然而，在发出警告之后，临床医生、政策制定者和患者仍然需要在重要的治疗问题上提供指导。我们建议汇集3个开始抗抑郁治疗的患者的大队列(Medicaid&lt；65；Medicare 65+，以及不列颠哥伦比亚省的全省人群队列)，并将这些使用与他们的医疗保健利用数据联系起来。我们将使用几种创新的分析方法来产生有助于指导治疗选择的数据。具体地说，我们将回答以下研究问题：1)根据类别、特定药物、剂量和使用时间确定抗抑郁药物使用者的自杀率。2)确定可能改变抗抑郁药物使用和自杀之间关系的社会人口学、临床和伴随治疗因素。3)确定FDA的行动对抗抑郁药的使用和临床结果的影响。4)确定治疗开始后患者监测的模式和潜在的可修改的决定因素，以帮助设计和瞄准未来的风险管理干预措施。5)评估和改进医院和急诊室入院时对自杀未遂进行编码的准确性。这项由经验丰富的跨学科团队使用多种分析方法进行的大型药物流行病学研究将评估围绕抗抑郁药物治疗安全性的最关键问题，并将为开发和瞄准更好的处方和风险管理策略提供指导。

DESCRIPTION (provided by applicant): In October 2004, the U.S. Food and Drug Administration (FDA) issued an advisory that antidepressants may be associated with an increased risk of suicidal thoughts and behaviors in children and adolescents. These warnings were prompted by its meta-analysis of all available randomized trials of antidepressants in this age group, in which patients randomized to antidepressants had nearly twice the rate of suicidal ideation or behavior relative to those given placebo. However, following the warnings clinicians, policymakers, and patients still need guidance on important treatment questions. We propose pooling 3 large cohorts of patients who initiated antidepressant therapy (Medicaid <65; Medicare 65+, and a province-wide population-based cohort in British Columbia) and link that use to data on their health care utilization. We will employ several innovative analytic methods to produce data that will help guide treatment choices. Specifically, we will answer the following research questions: 1) Identify the rates of suicidality in users of antidepressants in terms of class, specific agents, dosages, and durations of use. 2) Identify sociodemographic, clinical, and concomitant treatment factors that may modify the relationship between antidepressant use and suicidality. 3) Identify the impact of FDA actions on antidepressant utilization and clinical outcomes. 4) Identify patterns and potentially modifiable determinants of patient monitoring after initiation of therapy to help design and target future risk management interventions. 5) Assess and improve the accuracy of coding attempted suicide in hospital and emergency room admissions. This large pharmacoepidemiologic study by an experienced interdisciplinary team using multiple analytic methods will assess the most critical issues surrounding the safety of antidepressant therapy, and will provide guidance to develop and target better prescribing and risk management strategies.