跳至主要内容
临床试验/NCT03602521
NCT03602521已完成不适用

Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress : Pathophysiology of Suicidal Behaviors Study Model

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2019年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
116
试验地点
2
主要终点
Variation of plasma oxytocin concentrations after an interpersonal stress

研究概览

简要总结

Use lay language.

According to the World Health Organization 1 death by suicide occurs every 40 seconds, leading suicide prevention to one of the public health priority.

BPD (Borderline Personality Disorder) is a common condition affecting 6% of the population.

This disorder is characterized by unstable emotions, unstable mood, difficulties with relationship and feer of abandonment.

Borderline Personality Disorder is also the psychopathology the most related to suicidal attempts.

Indeed, up to 50% of the patients admitted to hospital after a suicide attempt are diagnosis with a Borderline Personality Disorder

Negative interpersonal events (events occurring between two people) are known as the main stressor that trigger a suicidal attempt.

People with a Borderline Personality Disorder are highly sensitive to it.

Moreover, neuropeptides such as oxytocin (OXT), vasopressin and opioid are known to be involved in the regulation of the emotions, especially those linked to relationship.

The purpose of this study is to improve knowledge in suicidal behaviors.

After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of patients with a BPD will be compared to healthy controls (HC).

Clinical data reflecting how the participant is feeling will be collected as well.

详细描述

A dysregulation of the neuropeptides (OXT, vasopressin and opioid) could explain the dysregulation of the emotions of people with Borderline Personality Disorder.

Up to this date there is no other study measuring neuropeptides kinetics of patient with Borderline Personality Disorder after an interpersonal stress.

This task of stress is meant to reproduce what people with Borderline Personality Disorder suffer in their everyday life (ecological).

To reach this point, an imaginary interpersonal stress will be asked to be reproduced by the participants.

Neuropeptides concentrations and clinical data (fear, shame, anger, moral pain, compelling needs (suicidal and non-suicidal)) will be collected at different times (pre stress, post stress immediat, 5 minutes post stress,15 minutes post stress and 40 minutes post stress)

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • No specific inclusion criteria :
  • If taking hormonal contraceptive: able to participate between the 3rd and 18th day after taking the contraceptive If not taking hormonal contraceptive: able to participate between the 5th and 12th day after the first day of the last period
  • Able to understand the nature, purpose and methodology of the study
  • Having signed the informed consent
  • To be affiliated to a social security scheme
  • Specific inclusion criteria
  • Borderline Personality Disorder(BPD) :
  • Clinical diagnosis of BPD using the SCID II (Structured Clinical Interview for DSM-IV-TR Axis II Personality Disorders)
  • Healthy controls:
  • No personal history of psychiatric disorders (Axis I ) defined by the MINI International Neuropsychiatric Interview according to the DSM-5 criteria

排除标准

  • Refusal of participation
  • Subject protected by law (guardianship)
  • Life time diagnosis of schizoaffective disorder or schizophrenia
  • Pregnant or breastfeeding women
  • Deprived of liberty Subject (by judicial or administrative decision)
  • Exclusion period in relation to another protocol
  • Having reached the maximum annual amount of allowances of € 4,500

结局指标

主要结局

Variation of plasma oxytocin concentrations after an interpersonal stress

时间窗: from pre interpersonal stress to 5 minutes post stress

Evaluate and compare the variation of plasma oxytocin concentrations before and after an interpersonal stress of patients with BPDs vs healthy controls between pre stress to 5 minutes post interpersonal stress.

次要结局

  • Clinical variable: self-damaging compelling needs(non-suicidal)(pre stress before the interpersonal stress)
  • Clinical variable: state of shame(pre stress just before the interpersonal stress)
  • Evolution of plasma copeptin concentrations(from pre stress to 40 minutes post interpersonal stress)
  • Evolution of plasma β-endorphin concentrations(from pre stress to 40 minutes post interpersonal stress)
  • Evolution of clinical variables: self-damaging compelling needs(suicidal)(from pre stress to 40 minutes post interpersonal stress)
  • Evolution of clinical variables: self-damaging compelling needs(non-suicidal)(from post stress immediat to 40 minutes just after the interpersonal stress)
  • Evolution of self-damaging compelling needs(non-suicidal)(from post stress immediat to 40 minutes just after the interpersonal stress)
  • Evolution of plasma oxytocin concentrations(from pre stress to 40 minutes post interpersonal stress)
  • Evolution of clinical variables: state of shame(from post stress immediat to 40 minutes just after the interpersonal stress)
  • Evolution of clinical variables: state of fear(from post stress immediat to 40 minutes just after the interpersonal stress)
  • self-damaging compelling needs(suicidal) pre stress(pre stress before the interpersonal stress)
  • Evolution of clinical variables: psychological pain(from post stress immediat to 40 minutes just after the interpersonal stress)
  • Clinical variable: state of anger(pre stress just before the interpersonal stress)
  • psychological pain(pre stress just before the interpersonal stress)
  • Evolution of clinical variables: state of anger(from post stress immediat to 40 minutes just after the interpersonal stress)
  • Clinical variable: state of fear(pre stress just before the interpersonal stress)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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