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临床试验/NCT03026387
NCT03026387招募中不适用

Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2017年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
650
试验地点
1
主要终点
Frequency of suicidal relapse according to aggressive impulsivity.

研究概览

简要总结

Suicidal behavior (SB) is a major public health problem in France, with over 10,000 suicides (6th in the EU28) and 220,000 suicide attempts (SA) per year. These data seem underestimated by 20%. A large percentage of men (6%) and women (9%) in France made at least one lifetime SA. In addition, SBs are common among young people and are the second leading cause of death among 15-44 year-olds. The interaction of multiple factors in SB complicates the creation of predictive models. These are currently imprecise and prevent the development of consensual recommendations for the management of suicidal patients.

Most suicide attempters are evaluated in the emergency room where it is imperative to identify people with a high risk of relapse. Risk assessment is generally based on the experience of the practitioner who uses psychometric scales as support for clinical decisions. This assessment could be improved and supplemented by other sources of information. Thus, we aim to develop a short and specific tool that combines:

  1. Neurocognitive measures carried out using computer software on domains strongly associated with SB: impulsivity, affective dysregulation, alterations in decision-making (risky choices), selective attention and verbal fluency.
  2. Clinical and psychological assessment including the most predictive items of future SA: life events (environment) and personality traits (vulnerability). Suicide attempters will be assessed for SB and suicidal ideation in the emergency department. These measures will be repeated during a 12-month follow-up. We will use the data obtained to provide a more accurate measure of risk.

详细描述

Over 65 months, 5 emergency departments (Montpellier, Nimes, Uzès, Nice, Marseille) will recruit a total of 650 patients who attempted suicide.

  • First visit: clinical and neuropsychological assessment
  • Second and third visits at 6 and 12 months: assessment of SBs and suicidal relapse, clinical and neuropsychological assessment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Being at least 18 years old
  • •Have committed a suicide attempt within 7 days prior to inclusion
  • •Receive minimal treatment (assessed by the clinician)
  • •Sign the informed consent
  • •Be able to understand the nature, the aims and the methodology of the study

排除标准

  • •Patient with an actual or past history of psychotic disorder
  • •Patient not affiliated to a French social security system.
  • •Patient deprived of liberty (judicial or administrative decision)
  • •Patient aged 65 years or older with an MMSE score <24 at baseline.
  • •Patient in exclusion period after participation in another project
  • •Patient who has already achieved 4500€ of annual research allowances

研究组 & 干预措施

Neuropsychological battery tests

Other

All participants performed the same evaluation: clinical and neuropsychological assessment.

All of them are suicide attempters without psychotic features

干预措施: Neuropsychological battery tests (Behavioral)

结局指标

主要结局

Frequency of suicidal relapse according to aggressive impulsivity.

时间窗: 12 months

aggressive impulsivity will be assessed by the capacity to inhibit responses during a Continuous Performance Task (CPT)

次要结局

  • Characteristics of suicidal behaviors assessed by Columbia Suicide History Form and the Columbia Suicide Severity Rating Scale(12 months)
  • Score of a short scale of suicidal risk assessment(12 months)
  • Intensity of suicidal ideation assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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