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临床试验/NCT02858635
NCT02858635Unknown不适用

Molecular Genetics of Suicidal Behavior: Study of Association Between Aggressive Impulsiveness and Genes of the Serotoninergic System

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 1,982 人开始时间: 2001年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,982
试验地点
2
主要终点
occurrence of suicide attempt

研究概览

简要总结

Suicide is a major health problem that causes annually a million death worldwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. According to this model, individuals who carry a suicidal act when subjected to stress factors (environmental stress, depression, substance ...) are those which have a specific vulnerability.These vulnerabilities can be considered as clinical parameters (propensity to despair, aggressive and/or impulsive traits), neurobiological parameters (dysfunction of the serotonergic system, ...) and cognitive parameters (taking disadvantageous decision ...). Suicidal vulnerability is partly underpinned by genetic factors. The interest of current researches is to identify biomarkers that will improve the opportunities for early identification of subject with a risk for SB.

The four goals of this project are in the continuity of previous works team:

  1. To determine whether combinations of the main serotonin-related genes may better contribute to the vulnerability to SB, than when they are considered independently.
  2. To assess whether the associations between these genes and SB are modulated by childhood trauma, life events and stress response associated with these environmental factors.
  3. To test the value of combined clinical, neuropsychological and genetic factor for suicide prevention, in a prospective study, in particularity impulsivity and gene gene interaction.
  4. To investigate the association between events in real life (using ecological momentary assessment) and emotional response and suicidal ideation.

The investigators propose to use a multidisciplinary approach to answer these questions and, hence, be able to identify new prevention strategies for SB.

详细描述

Transversal study:

1500 patients with a personal history of suicide attempt will be recruited. Clinical, biological and neuropsychological assessments will be performed. The first objective of the study is to replicate the results already obtained regarding the association between serotonergic system genes and suicidal behaviour. The allele frequencies for different markers tested in suicidal and in control subjects with no history of suicidal behaviour will be compared. The patients that will be recruited will be compared to the control population already recruited for another project.

Prospective study: 554 patients hospitalized for a suicide attempt will will be evaluated, each 6 month, during the 2-years period of the study. Clinical, biological and neuropsychological assessments will be performed.

At the end of the inclusion visit, 60 participants will be assessed using ecological momentary assessment(ESM). They will be instructed to carry a smartphone with them for one week, and to record at each alarm signal daily life events, negative emotions, psychological pain, suicidal ideas, and specific attributions to these events. Participants will be signalled five times a day during the period. Subjects will be contacted by telephone halfway through the assessment period to monitor and encourage compliance.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • personal history of suicide attempt
  • French Caucasian Western Europe and specifically have all four grandparents from a country in Western Europe (for genetics purposes)
  • able to understand nature, aims, and methodology oh the study
  • do not emphasize to leave during the time-study.

排除标准

  • Pregnancy
  • Not able to speak, read and understand French
  • Patient on protective measures (guardianship or trusteeship)

结局指标

主要结局

occurrence of suicide attempt

时间窗: up to 6 months

occurrence of a suicide attempt will be assessed by the Columbia History Form at each visit

次要结局

  • number of suicide attempt(1 hour)
  • lethality of suicide attempt(1 hour)
  • psychological pain(1 hour)
  • type of suicide attempt(1 hour)
  • suicidal ideation(up to 7 days)
  • aggressiveness(1 hour)
  • anger(1 hour)
  • Impulsivity(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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