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，食品药品监督管理局（FDA）指示药物制造商向抗抑郁药添加黑匣子警告，描述了儿童自杀的风险增加。 FDA裁决引起了争议，反映了与科学不确定性条件下权衡风险与利益相关的基本权衡。支持者认为，与在青年中使用抗抑郁药有关的自杀风险升高的证据非常严重，可以保证告知提供者和消费者。批评家反驳说，FDA行动将减少对抑郁症的有效治疗方法，从而在未经治疗的人群中产生较差的心理健康成果（包括对自杀风险的上下压力）。该申请研究了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，本应用的主要重点不是抗抑郁药是否会增加自杀风险，而是个人受到有效治疗的疾病的风险增加。 AIM 1评估FDA行动对重度抑郁症和焦虑诊断儿童和成人治疗选择的影响。 AIM 2检查了FDA行动对接受重大抑郁症诊断的儿童和成人的适当治疗的影响。 AIM 3研究归因于FDA作用对医学治疗的自杀未遂指标的抗抑郁药中下降的影响。 AIM 4评估药物制造商是否根据FDA行动改变了促销内容和策略。来自大量被保险人群的门诊，住院和药物索赔数据将用于进行目标1-3。随着时间的流逝，将遵循个人，并将构建治疗发作，以评估调节如何影响治疗选择和接受适当的护理。在AIM 4中，将采用一种混合方法来发展对制造商反应的丰富理解，而不是仅从定量或定性方法中确定。该申请的前提是，政策决策带来了预期收益和意外后果的必然性。指导应用程序的广泛目标是促进一种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。由于抑郁症的治疗不足是美国的实质性公共卫生问题，因此替代治疗方法增加而降低了抗抑郁治疗的降低不是理想的政策结果。该项目的重要性在于其潜力有可能帮助临床医生和政策制定者评估和管理竞争风险并受益于索赔。