SSRIs and Self-harm in Borderline Personality Disorder

SSRIs 与边缘性人格障碍中的自残

基本信息

批准号：
8478196
负责人：
EMIL Frank COCCARO
金额：
$ 50.67万
依托单位：
UNIVERSITY OF CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-08-25 至 2015-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8478196
关键词：
Acute Affective Age Aggressive behavior Auditory Evoked Potentials Behavior Borderline Personality Disorder Boxing Case Study Clinical Trials Data Dependence Depressed mood Depressive disorder Diagnosis Disease Double-Blind Method Emotions Escitalopram Exposure to Feeling suicidal Functional disorder Genetic Genetic Polymorphism Home environment Impulsivity Individual Institutes Label Laboratories Lead Link Loudness Major Depressive Disorder Measurement Measures Medical Mental Depression Meta-Analysis Methodology Methods Outcome Participant Patient Self-Report Patients Pharmaceutical Preparations Pharmacological Treatment Phase Placebos Population Psychophysiology Randomized Randomized Clinical Trials Reporting Research Risk Sampling Selective Serotonin Reuptake Inhibitor Self-Injurious Behavior Serotonin Suicide Suicide prevention Symptoms Thinking Time analog base blind clinically relevant economic cost ideation indexing information processing promoter prospective public health relevance randomized trial reducing suicide response social suicidal suicide rate trait translational approach trial comparing week trial

项目摘要

DESCRIPTION: Suicide and lesser forms of intentional self-harm behaviors produce devastating medical, social and economic costs. Self-harm is integrally related to depressive disorders and Borderline Personality Disorder. Selective Serotonin Reuptake Inhibitors (SSRIs), like escitalopram, are front-line pharmacological treatments for these disorders, putatively regulating depressed mood and reducing suicidality. However, data from case studies and retrospective meta-analyses of depression clinical trials is mixed, with some (but not all ) studies suggesting that during the first months of treatment, SSRIs may increase the risk of suicidal ideation in select individuals, particularly younger individuals. These post-hoc analyses, though informative, are based on studies that provide limited sampling of the self-harm domain. No study, to date, has implemented a direct prospective examination of the effects of early SSRI use on self-harm thoughts and behaviors using a multi-method measurement involving both the laboratory (standard self-aggression paradigm: SAP) and home environments (ecological momentary assessment: EMA). Also, no study has examined the influence of impaired 5-HT function and emotion dysregulation as moderators of outcome with escitalopram. The proposed randomized clinical trial will prospectively assess the impact of eight weeks exposure to SSRI treatment on self-harm ideation and behavior among a sample of 200 subjects with Borderline Personality Disorder and current major depression. After a one week single-blind placebo lead-in, participants will be randomly assigned double blind to either placebo or escitalopram for eight (8) weeks. The primary dependent variable will be EMA of self-harm ideation and behavior obtained several times each day. Self-harm will also be assessed using a laboratory analogue task (SAP) at baseline and again after the eight week trial. Age will be evaluated as a moderator of SSRI response. 5-HT dysfunction and emotion dysregulation will be evaluated as candidate moderators of SSRI response. 5-HT functioning will be assessed using psychophysiological (loudness dependence of the auditory evoked potential: LDAEP) and genetic (5-HT transporter promoter polymorphism: 5-HTTLPR) markers. Measures of emotion dysregulation will include trait aggression, impulsivity and socioemotional information processing. At the conclusion of the eight-week randomized trial, all participants will receive eight weeks of escitalopram administered single-blind, with continued EMA and other assessment.

描述：自杀和较小形式的故意自残行为会造成毁灭性的医疗、社会和经济成本。自残与抑郁症和边缘性人格障碍密切相关。选择性血清素再摄取抑制剂 (SSRI)，如艾司西酞普兰，是这些疾病的一线药物治疗方法，可以调节抑郁情绪并减少自杀倾向。然而，来自案例研究和回顾性荟萃分析的数据抑郁症的临床试验好坏参半，一些（但不是全部）研究表明，在第一次治疗期间经过数月的治疗，SSRIs 可能会增加特定个体，尤其是年轻人的自杀意念风险。这些事后分析虽然内容丰富，但基于提供自残领域有限样本的研究。迄今为止，还没有研究使用涉及实验室（标准自我攻击范式：SAP）和家庭环境（生态环境）的多方法测量，对早期使用 SSRI 对自残思想和行为的影响进行直接前瞻性检查。瞬时评估：EMA）。此外，尚无研究探讨 5-HT 功能受损和情绪失调作为艾司西酞普兰结局调节因素的影响。拟议的随机临床试验将前瞻性地评估 200 名患有边缘性人格障碍和目前重度抑郁症的受试者接受 SSRI 治疗八周对自残观念和行为的影响。经过一周的单盲安慰剂导入后，参与者将被随机分配至安慰剂或艾司西酞普兰双盲组，为期八 (8) 周。主要因变量是每天多次获得的自残意念和行为的 EMA。还将在基线时和八周试验后使用实验室模拟任务（SAP）对自残进行评估。年龄将作为 SSRI 反应的调节因素进行评估。 5-HT 功能障碍和情绪失调将作为 SSRI 反应的候选调节因子进行评估。将使用心理生理学（听觉诱发电位的响度依赖性：LDAEP）和遗传（5-HT转运蛋白启动子多态性：5-HTTLPR）标记来评估5-HT功能。情绪失调的衡量标准包括攻击性、冲动性和社会情绪信息处理。在为期八周的随机试验结束时，所有参与者将接受八周的单盲艾司西酞普兰治疗，并继续进行 EMA 和其他评估。