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: 7664344
• 负责人: Sebastian G. Schneeweiss
• 金额: $ 17.83万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-26 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7664344
• 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，美国食品药品监督管理局（FDA）发布了一项咨询，即抗抑郁药可能与儿童和青少年自杀思想和行为的风险增加有关。这些警告是由于该年龄段的所有可用抗抑郁药随机试验的荟萃分析引起了这些警告，在该年龄段中，随机分配给抗抑郁药的患者的自杀念头或行为率几乎是给定安慰剂的人的两倍。但是，在警告临床医生，决策者和患者之后，仍然需要有关重要治疗问题的指导。我们提出了汇集3个大量的抗抑郁药治疗（Medicaid <65; Medicare 65+）的患者，并在不列颠哥伦比亚省的一个范围内基于人口的同类群）将其与医疗保健利用的数据联系起来。我们将采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。具体来说，我们将回答以下研究问题：1）在班级，特定代理，剂量和使用持续时间方面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和自杀性之间关系的社会人口统计学，临床和伴随的治疗因素。 3）确定FDA作用对抗抑郁药利用和临床结果的影响。 4）确定启动治疗后患者监测的模式和可能修改的决定因素，以帮助设计和针对未来的风险管理干预措施。 5）评估和提高在医院和急诊室入院中自杀的编码准确性。经验丰富的跨学科团队使用多种分析方法进行的这项大型药物ePidemiologic研究将评估围绕抗抑郁治疗安全的最关键问题，并将提供指导，以开发和针对更好的处方和风险管理策略。

项目成果

Differential risk of death in older residents in nursing homes prescribed specific antipsychotic drugs: population based cohort study.

• DOI: 10.1136/bmj.e977
• 发表时间: 2012-02-23
• 期刊: BMJ (Clinical research ed.)
• 作者: Huybrechts KF;Gerhard T;Crystal S;Olfson M;Avorn J;Levin R;Lucas JA;Schneeweiss S
• 通讯作者: Schneeweiss S