SSRIs and Self-harm in Borderline Personality Disorder

SSRIs 与边缘性人格障碍中的自残

• 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
• 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

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。这些事后分析虽然信息丰富，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（生态瞬时评估：EMA）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。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，所有参与者都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。