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:8662789
- 负责人:
- 金额:$ 6.59万
- 依托单位:
- 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 2014-11-30
- 项目状态:已结题
- 来源:
- 关键词:AcuteAffectiveAgeAggressive behaviorAuditory Evoked PotentialsBehaviorBorderline Personality DisorderBoxingCase StudyClinical TrialsDataDependenceDepressed moodDepressive disorderDiagnosisDiseaseDouble-Blind MethodEmotionsEscitalopramExposure toFeeling suicidalFunctional disorderGeneticGenetic PolymorphismHome environmentImpulsivityIndividualInstitutesLabelLaboratoriesLeadLinkLoudnessMajor Depressive DisorderMeasurementMeasuresMedicalMental DepressionMeta-AnalysisMethodologyMethodsOutcomeParticipantPatient Self-ReportPatientsPharmaceutical PreparationsPharmacological TreatmentPhasePlacebosPopulationPsychophysiologyRandomizedRandomized Clinical TrialsReportingResearchRiskSamplingSelective Serotonin Reuptake InhibitorSelf-Injurious BehaviorSerotoninSuicideSuicide preventionSymptomsThinkingTimeanalogbaseblindclinically relevanteconomic costideationindexinginformation processingpromoterprospectiverandomized trialreducing suicideresponsesocialsuicidalsuicide ratetraittranslational approachtrial comparingweek 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.
自杀和较轻形式的故意自我伤害行为产生毁灭性的医疗,社会和经济成本。自我伤害与抑郁症和边缘型人格障碍密切相关。选择性5-羟色胺再摄取抑制剂(SSRIs),如艾司西酞普兰,是这些疾病的一线药物治疗,可调节抑郁情绪
减少自杀倾向。然而,来自病例研究和回顾性荟萃分析的数据,
抑郁症的临床试验是混合的,一些(但不是全部)研究表明,在第一次
SSRIs可能会增加特定个体,特别是年轻个体的自杀意念风险。这些事后分析,虽然信息丰富,是基于研究,提供有限的抽样自残域。到目前为止,还没有一项研究采用多方法测量方法对早期使用SSRI对自我伤害思想和行为的影响进行直接的前瞻性检查,该方法涉及实验室(标准自我攻击范式:SAP)和家庭环境(生态瞬时评估:EMA)。此外,还没有研究检查5-HT功能受损和情绪失调作为艾司西酞普兰结局调节因子的影响。拟议的随机临床试验将前瞻性地评估8周SSRI治疗对200名患有边缘型人格障碍和当前重度抑郁症的受试者的自我伤害想法和行为的影响。在一周的单盲安慰剂导入期后,受试者将被随机双盲分配至安慰剂组或艾司西酞普兰组,持续八(8)周。主要因变量将是每天多次获得的自我伤害想法和行为的EMA。还将在基线时使用实验室模拟任务(SAP)评估自我伤害,并在8周试验后再次评估。年龄将作为SSRI反应的调节因素进行评价。5-HT功能障碍和情绪失调将作为SSRI反应的候选调节剂进行评估。将使用心理生理学(听觉诱发电位的响度依赖性:LDAEP)和遗传学(5-HT转运蛋白启动子多态性:5-HTTLPR)标志物评估5-HT功能。情绪失调的测量将包括特质攻击性、冲动性和社会情绪信息处理。在为期8周的随机试验结束时,所有受试者将接受为期8周的艾司西酞普兰单盲给药,并继续进行EMA和其他评估。
项目成果
期刊论文数量(3)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Development and validation of empirically derived frequency criteria for NSSI disorder using exploratory data mining.
- DOI:10.1037/pas0000334
- 发表时间:2017-02
- 期刊:
- 影响因子:3.6
- 作者:Ammerman, Brooke A.;Jacobucci, Ross;Kleiman, Evan M.;Muehlenkamp, Jennifer J.;McCloskey, Michael S.
- 通讯作者:McCloskey, Michael S.
Measuring Acquired Capability for Suicide within an Ideation-to-Action Framework.
- DOI:10.1037/vio0000090
- 发表时间:2018-03
- 期刊:
- 影响因子:2.8
- 作者:Burke TA;Ammerman BA;Knorr AC;Alloy LB;McCloskey MS
- 通讯作者:McCloskey MS
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{{ truncateString('EMIL Frank COCCARO', 18)}}的其他基金
Nitrous Oxide and Cortico-Limbic Function in Aggression
攻击行为中的一氧化二氮和皮质边缘功能
- 批准号:
9896211 - 财政年份:2020
- 资助金额:
$ 6.59万 - 项目类别:
Nitrous Oxide and Cortico-Limbic Function in Aggression
攻击行为中的一氧化二氮和皮质边缘功能
- 批准号:
10250307 - 财政年份:2020
- 资助金额:
$ 6.59万 - 项目类别:
Aggression and SEIP: Neural Correlates During Alcohol Intoxication
攻击性和 SEIP:酒精中毒期间的神经相关性
- 批准号:
10266858 - 财政年份:2020
- 资助金额:
$ 6.59万 - 项目类别:
Development of fMRI Studies of Social-Emotional Information Processing
社会情感信息处理的功能磁共振成像研究进展
- 批准号:
8702238 - 财政年份:2013
- 资助金额:
$ 6.59万 - 项目类别:
Development of fMRI Studies of Social-Emotional Information Processing
社会情感信息处理的功能磁共振成像研究进展
- 批准号:
8583812 - 财政年份:2013
- 资助金额:
$ 6.59万 - 项目类别:
SSRIs and Self-harm in Borderline Personality Disorder
SSRIs 与边缘性人格障碍中的自残
- 批准号:
7890200 - 财政年份:2010
- 资助金额:
$ 6.59万 - 项目类别:
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 - 财政年份:2010
- 资助金额:
$ 6.59万 - 项目类别:
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 - 财政年份:2010
- 资助金额:
$ 6.59万 - 项目类别:
SSRIs and Self-harm in Borderline Personality Disorder
SSRIs 与边缘性人格障碍中的自残
- 批准号:
8308694 - 财政年份:2010
- 资助金额:
$ 6.59万 - 项目类别:
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