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临床试验/NCT03209102
NCT03209102进行中(未招募)2 期

Multimodal Study of the Emotional Regulation and Impulsivity Among Adolescents with Borderline Personality Disorder : Stress Reactivity and Functional Imaging

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年10月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
66
试验地点
1
主要终点
Comparison between subjective and objective acute stress experience in BPD Adolescents vs Healthy controls

研究概览

简要总结

This study aims to better understand the behavioral, neurobiological and hormonal underpinnings of stress and reward reactivity of adolescents suffering from borderline personality disorder compared to healthy adolescents by a multimodal approach based on clinical assessments, structural and functional mri and experimental acute stress exposure.

详细描述

Borderline Personality Disorder (BPD) is a severe condition associated with intense emotional and behavioral responses to stressful events, impulsivity, and risk-taking behavior. It has been shown to begin in adolescence. However, very few studies have addressed the physiopathology of BPD in adolescents. In order to gather rational information for targeted care, the heterogeneity of BPD determinants needs to be disentangled. To this aim, a multimodal approach to BPD dimensional aspects is proposed.

BPD adolescents will be compared to typically developing controls in two complementary experimental designs: (1) Monitoring of neurovegetative, hormonal and body motion responses to an acute stress, with the hypothesis that stress reactivity might account for the physiopathology of the disorder; (2) Structural and functional imaging (fMRI BOLD) in the context of a reward processing task to delineate the neural/functional basis of BPD risk taking behavior.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescent subject: 13 years ≤ age ≤ 18years
  • Affiliation to social welfare
  • Informed consent to participate in the protocol, consent signed by the major subject or by one of the legal guardians if the subject is a minor
  • Diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) and Abbreviated- Diagnostic Interview of Borderline Personality Disorder (Ab-DIB)
  • Somatic and intellectual state compatible with blood sampling and MRI examination

排除标准

  • Non-affiliation to social welfare
  • Refusal to give consent and / or to sign informed consent by the subject or his or her legal guardian if the subject is a minor
  • Somatic pathology in progress, or pregnancy (urine test of pregnancy in case of doubt)
  • Contraindication to magnetic resonance imaging:
  • Presence of a ferromagnetic foreign body
  • Subject carrying a pacemaker
  • Subject carrying ventricular bypass valves
  • Claustrophobic topic
  • Subject suffering from the following diseases:
  • Intellectual impairment Intellectual Quotient (IQ) <70,
  • Claustrophobia,
  • Obsessive Compulsive Disorder,
  • Tic Disorder,
  • Autism Spectrum Disorder,
  • Attention Deficit Disorder with or without Hyperactivity,
  • Bipolar disorder,
  • Schizophrenia

研究组 & 干预措施

BPD adolescents

Experimental

Adolescents suffering from Borderline Personality Disorder. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol

干预措施: Clinical assessment (Other)

BPD adolescents

Experimental

Adolescents suffering from Borderline Personality Disorder. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol

干预措施: Stress elicitation experiment (Behavioral)

BPD adolescents

Experimental

Adolescents suffering from Borderline Personality Disorder. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol

干预措施: Structural and Functional MRI (Other)

BPD adolescents

Experimental

Adolescents suffering from Borderline Personality Disorder. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol

干预措施: salivary collections of amylase and cortisol (Biological)

Healthy controls adolescents

Experimental

Healthy controls adolescents. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol

干预措施: Clinical assessment (Other)

Healthy controls adolescents

Experimental

Healthy controls adolescents. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol

干预措施: Stress elicitation experiment (Behavioral)

Healthy controls adolescents

Experimental

Healthy controls adolescents. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol

干预措施: Structural and Functional MRI (Other)

Healthy controls adolescents

Experimental

Healthy controls adolescents. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol

干预措施: salivary collections of amylase and cortisol (Biological)

结局指标

主要结局

Comparison between subjective and objective acute stress experience in BPD Adolescents vs Healthy controls

时间窗: up to 3 months

Comparing subjective (by self-assessment) and objective response to acute stress by measuring the biological (stress hormones and enzymes) and neurovegetative responses to stress and assessing the motor responses to stress by using novel approaches based on specific machine learning algorithms.

Investigating the neural correlates and modulation of motivation and impulsivity using structural and task-based fMRI

时间窗: up to 3 months

The fMRI session will provide three types of data: (1) task-related activity to probe the striato-limbic and prefrontal regions, (2) resting state connectivity to examine the integrity of canonical networks, and (3) MR structural images to measure regional volumes of key functional nodes. For the task-related fMRI study, the investigators will use the monetary incentive delay task that reliably elicit an activation in known functional networks underlying reward anticipation/outcome.

次要结局

未报告次要终点

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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