SSRIs and Self-harm in Borderline Personality Disorder

SSRIs 与边缘性人格障碍中的自残

• 批准号: 8134231
• 负责人: EMIL Frank COCCARO
• 金额: $ 53.28万
• 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/8134231
• 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. PUBLIC HEALTH RELEVANCE: The proposed randomized clinical trial will prospectively assess the impact of 8 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 daily for eight (8) weeks. The primary dependent variable will be EMA of self-harm ideation and behavior obtained several times each day. Selfharm will also be assessed using a laboratory analogue task (SAP) at baseline and again after the eight week trial. Age, 5-HT dysfunction and emotion dysregulation will be evaluated as potential moderators of SSRI response.

描述：自杀和较少形式的故意自我伤害行为会产生毁​​灭性的医疗，社会和经济成本。自我伤害与抑郁症和边缘性人格障碍完全相关。选择性5-羟色胺再摄取抑制剂（SSRIS），例如依源妥二酸酯，是这些疾病的前线药理治疗方法，可预测调节情绪低落 并减少自杀性。但是，来自案例研究和回顾性荟萃分析的数据 抑郁临床试验是混合的，有些（但不是全部）研究表明，在第一个研究中 几个月的治疗，SSRI可能会增加某些个体，尤其是年轻人的自杀意念的风险。这些事后分析虽然有益，但基于提供有限的自我伤害域采样的研究。迄今为止，尚无对早期使用SSRI使用对自我伤害思想和行为的影响进行的直接前瞻性检查，该影响使用涉及实验室（标准自我攻击范式：SAP）和家庭环境（生态瞬时评估：EMA）的多方法测量值（标准自我攻击范式：SAP）。同样，尚无研究检查5-HT功能和情绪失调作为依他张兰州结果的主持人的影响。提出的随机临床试验将前瞻性评估八周暴露于SSRI治疗对200名具有边缘性人格障碍和当前重大抑郁症患者样本的自我伤害意见和行为的影响。经过一周的单盲安慰剂介入后，参与者将被随机分配给安慰剂或依他张兰am八（8）周。主要的因变量将是每天获得多次自我伤害构想和行为的EMA。在基线和八周试验后，还将使用实验室模拟任务（SAP）评估自我伤害。年龄将作为SSRI反应的主持人评估。 5-HT功能障碍和情绪失调将被评估为SSRI反应的候选主持人。 5-HT功能将使用心理生理学（听觉引起的潜力的响度依赖性：LDAEP）和遗传（5-HT转运蛋白启动子多态性：5-HTTLPR）标记进行评估。情绪失调的度量将包括特质侵略，冲动和社会情感信息处理。在为期八周的随机试验结束时，所有参与者将接受八周的依源妥拉姆施用单盲，并继续进行EMA和其他评估。 公共卫生相关性：拟议的随机临床试验将前瞻性评估8周暴露于SSRI治疗对200名有边缘性人格障碍和当前重大抑郁症患者样本的自我伤害构想和行为的影响。经过一周的单盲安慰剂介入后，参与者每天将随机分配给安慰剂或依他张兰am的双眼盲人，持续八（8）周。主要的因变量将是每天获得多次自我伤害构想和行为的EMA。在基线和八周试验后，还将使用实验室模拟任务（SAP）进行自我障碍。年龄，5-HT功能障碍和情绪失调将被评估为SSRI响应的潜在主持人。