Antidepressant Use and Suicidality: Comparative Safety in Children and Adults

抗抑郁药的使用和自杀：儿童和成人的相对安全性

• 批准号: 7929307
• 负责人: Sebastian G. Schneeweiss
• 金额: $ 16.01万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7929307
• 关键词: Accident and Emergency department; Admission activity; Adolescent; Adult; Age; Algorithms; Antide; Antidepressive Agents; Arts; Behavior; British Columbia; Child; Clinical; Code; Cohort Studies; Data; Databases; Demographic Factors; Diagnosis; Dose; Emergency Situation; Face; Feeling suicidal; Frequencies; Future; General Practitioners; Gestures; Hospitals; Individual; Intervention; Link; Medicaid; Medicare; Medicare/Medicaid; Meta-Analysis; Methods; Monitor; Morbidity - disease rate; Observational Study; Outcome; Patient Monitoring; Patients; Pattern; Pharmaceutical Preparations; Physicians; Placebos; Policy Maker; Predictive Value; Prevalence; Province; Publications; Randomized; Randomized Controlled Clinical Trials; Relative (related person); Reporting; Research; Research Personnel; Risk; Risk Management; Running; Safety; Scoring Method; Self-Injurious Behavior; Serotonin; Specialist; Suicide; Suicide attempt; Treatment Factor; Treatment Protocols; United States Food and Drug Administration; Visit; accomplished suicide; age group; base; cohort; comparative; depression; design; dosage; experience; health care service utilization; high risk; improved; innovation; man; population based; programs; reuptake; suicidal; suicide rate; time use; trend

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.

描述（由申请人提供）：2004 年 10 月，美国食品和药物管理局 (FDA) 发布了一项建议，称抗抑郁药可能会增加儿童和青少年自杀念头和行为的风险。这些警告是由该年龄组所有可用的抗抑郁药随机试验的荟萃分析得出的，其中随机接受抗抑郁药的患者的自杀意念或行为发生率是服用安慰剂的患者的近两倍。然而，根据警告，临床医生、政策制定者和患者仍然需要有关重要治疗问题的指导。我们建议汇集 3 个开始抗抑郁治疗的患者队列（Medicaid <65；Medicare 65+，以及不列颠哥伦比亚省全省范围内的人口队列），并将其与他们的医疗保健利用率数据联系起来。我们将采用几种创新的分析方法来生成有助于指导治疗选择的数据。具体来说，我们将回答以下研究问题：1）根据抗抑郁药的类别、具体药物、剂量和使用持续时间确定抗抑郁药使用者的自杀率。 2) 确定可能改变抗抑郁药使用与自杀之间关系的社会人口统计学、临床和伴随治疗因素。 3) 确定 FDA 行动对抗抑郁药物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可修改的决定因素，以帮助设计和确定未来的风险管理干预措施。 5) 评估并提高医院和急诊室入院时自杀未遂编码的准确性。这项大型药物流行病学研究由经验丰富的跨学科团队使用多种分析方法进行，将评估围绕抗抑郁治疗安全性的最关键问题，并将为制定和制定更好的处方和风险管理策略提供指导。

项目成果

Comparative safety of antipsychotic medications in nursing home residents.

• DOI: 10.1111/j.1532-5415.2011.03853.x
• 发表时间: 2012-03
• 期刊: Journal of the American Geriatrics Society
• 影响因子: 6.3
• 作者: Huybrechts KF;Schneeweiss S;Gerhard T;Olfson M;Avorn J;Levin R;Lucas JA;Crystal S
• 通讯作者: Crystal S

Health advisories and patterns of patient monitoring among new users of antidepressant medications.

抗抑郁药物新使用者的健康建议和患者监测模式。

• DOI: 10.1097/jcp.0b013e3181bf4eb9
• 发表时间: 2009
• 期刊: Journal of clinical psychopharmacology
• 影响因子: 2.9
• 作者: Gagne,JoshuaJ;Patrick,AmandaR;Wang,PhilipS;Schneeweiss,Sebastian
• 通讯作者: Schneeweiss,Sebastian

Comparative safety of antidepressant agents for children and adolescents regarding suicidal acts.

• DOI: 10.1542/peds.2009-2317
• 发表时间: 2010-05
• 期刊: Pediatrics
• 影响因子: 8
• 作者: Schneeweiss S;Patrick AR;Solomon DH;Dormuth CR;Miller M;Mehta J;Lee JC;Wang PS
• 通讯作者: Wang PS