Antidepressant Use and Suicide

抗抑郁药的使用和自杀

• 批准号: 7300000
• 负责人: Susan H Busch
• 金额: $ 31.42万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-01 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7300000
• 关键词: Adult; Affect; Antidepressive Agents; Anxiety; Area; Benefits and Risks; Boxing; Caring; Child; Childhood; Condition; Data; Decision Making; Diagnosis; Health Services; Health Services Research; Human Resources; Individual; Industry; Inpatients; Interview; Investigation; Link; Maintenance; Major Depressive Disorder; Manufacturer Name; Measures; Medical; Mental Depression; Mental Health; Mental Health Services; Mental disorders; Methods; Outcome; Outpatients; Pattern; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Policies; Population; Provider; Public Health; Purpose; Qualitative Methods; Quality of Care; Regulation; Reporting; Research Personnel; Risk; Structure; Suicide; Suicide attempt; Surgeon; Testing; Time; Uncertainty; United States Food and Drug Administration; Work; Youth; base; drug market; improved; pressure; programs; response; suicidal behavior; suicidal risk

DESCRIPTION (provided by applicant): In October 2004, the Food and Drug Administration (FDA) directed pharmaceutical manufacturers to add a black box warning to antidepressants describing the increased risk of suicidality in children. The FDA ruling elicited controversy reflecting the fundamental trade-offs associated with weighing risks against benefits under conditions of scientific uncertainty. Supporters argued that evidence of elevated risks of suicidality linked to use of antidepressants in youth was sufficiently serious to warrant informing providers and consumers. Critics countered that FDA actions would reduce the use of an effective treatment for depression thereby producing poorer mental health outcomes (including some upward pressure on the risk of suicide) in an under-treated population. This application examines the potential gains and unintended consequences of FDA regulatory policy. Unlike most prior work, the primary focus of this application is not whether antidepressants increase suicide risk, but rather the heightened risk of individuals being under or untreated for illnesses for which effective treatments exist. Aim 1 assesses the impact of FDA actions on treatment choice for children and adults with major depression and anxiety diagnoses. Aim 2 examines the impact of FDA actions on receipt of appropriate treatment for children and adults with a major depression diagnosis. Aim 3 studies the impact of declines in antidepressant use attributable to FDA action on indicators of medically-treated suicide attempts in youth. Aim 4 assesses whether pharmaceutical manufacturers altered promotional content and strategy in response to FDA actions. Outpatient, inpatient and pharmaceutical claims data from a large insured population will be used to conduct Aims 1-3. Individuals will be followed over time and episodes of treatment will be constructed to assess how regulation affects treatment choice and receipt of appropriate care. In Aim 4, a mixed methods approach will be employed to develop a richer understanding of manufacturer response than might be ascertained from either quantitative or qualitative methods alone. This application is premised on the inevitability of both expected benefits and unintended consequences arising from policy decisions. The broad objective that guides the application is to promote an evidence-based approach to understanding and managing uncertainty inherent in FDA regulatory decisions. Because under-treatment of depression is a substantial public health problem in the U.S., reductions in antidepressant treatment unaccompanied by increases in alternative treatments is not a desirable policy outcome. The significance of this project lies in its potential to help clinicians and policymakers assess and manage competing risk and benefit claims.

描述（由申请人提供）：2004 年 10 月，美国食品和药物管理局 (FDA) 指示药品制造商在抗抑郁药中添加黑框警告，描述儿童自杀风险增加。 FDA 的裁决引发了争议，反映出在科学不确定的情况下权衡风险与收益相关的基本权衡。支持者认为，青少年使用抗抑郁药导致自杀风险升高的证据非常严重，有必要告知医疗服务提供者和消费者。批评者反驳说，FDA 的行动将减少抑郁症有效治疗方法的使用，从而在治疗不足的人群中产生更差的心理健康结果（包括自杀风险的上升压力）。该应用程序检查了 FDA 监管政策的潜在收益和意外后果。与大多数先前的工作不同，该应用的主要焦点不是抗抑郁药是否会增加自杀风险，而是个体因存在有效治疗方法而未接受或未治疗的疾病的风险增加。目标 1 评估 FDA 行动对患有重度抑郁症和焦虑症的儿童和成人治疗选择的影响。目标 2 检查 FDA 行动对诊断为重度抑郁症的儿童和成人接受适当治疗的影响。目标 3 研究 FDA 对青少年自杀未遂药物治疗指标采取行动导致抗抑郁药物使用量下降的影响。目标 4 评估制药商是否根据 FDA 的行动改变促销内容和策略。来自大量受保人群的门诊、住院和药品索赔数据将用于实现目标 1-3。我们将随着时间的推移对个人进行跟踪，并构建治疗片段，以评估监管如何影响治疗选择和接受适当的护理。在目标 4 中，将采用混合方法来比单独通过定量或定性方法确定制造商响应更丰富的理解。该应用的前提是政策决策不可避免地会产生预期收益和意外后果。指导该申请的总体目标是推广基于证据的方法来理解和管理 FDA 监管决策中固有的不确定性。由于抑郁症治疗不足是美国的一个重大公共卫生问题，因此减少抗抑郁药物治疗而不增加替代治疗并不是理想的政策结果。该项目的意义在于它有可能帮助临床医生和政策制定者评估和管理竞争风险和利益主张。