跳至主要内容
临床试验/NCT02904005
NCT02904005Unknown不适用

National Multicentric Study on the Predictive Factors for Suicidal Behavior During a Major Depressive Episode

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
2
主要终点
Suicide attempt during follow-up

研究概览

简要总结

This study aims at identifying predictors of suicidal behaviors in depressed subjects. Investigators will first compare demographic, clinical, and biological features of depressed recent suicide attempters (within one week) and depressed subjects without lifetime history of suicide attempt. Baseline risk factors for suicide will be used to predict the risk of attempting suicide during a one year follow-up. A thorough evaluation of these patients will allow to identify the factors associated with suicidal risk and develop a simplified risk score that could be used in clinical settings to improve our practice.

详细描述

Background and rationale:

Suicidal behavior (SB) is a major health problem in France, with more than 10,000 suicides (6th UE28) and 220 000 suicide attempts (SA) per year. A large percentage of men (6%) and women (9%) in France have made at least one SA. Moreover, suicide is the second leading cause of death among the youngest (15-44 years). The clinical model currently admitted for understanding SB is a stress vulnerability model. But to date, scientists have not (yet) a clinical application for the research on SB. The management of psychiatric patients, including depressed subjects, faces the impossibility of detecting those at high risk of occurrence of SB. Indeed, although many risk factors for SB are known, their predictive value is very low. In addition, these risk factors are primarily derived from cross-sectional studies. The identification of predictors, using a standardized evaluation would allow clinicians to identify the subject at high risk of SB for which therapeutic interventions and the organization of care should be particularly aggressive and intensive.

Objectives:

Main objective: To identify predictors (clinical, biological, environmental) of the occurrence of SB during 12 months in a population of depressed suicide attempters and lifetime non attempters to optimize a short standardized evaluation applicable to emergency settings.

Secondary objectives: 1) To build a multidimensional score for predicting the risk of recurrence of suicide attempt among suicide attempters ; 2) To evaluate the prospective performance of this score to predict emergence of suicide attempt among depressed patients without history of suicide attempt; 3) To identify predictors of suicidal spectrum (suicidal thoughts, suicidal planification, suicide attempt and completed suicide) in depressed subjects ; 4) To evaluate the feasibility of a multicenter network that will use standardized assessments to evaluate suicidal risk through a secured website.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Suicide attempt during follow-up

时间窗: At one year

Evaluation of the occurrence of a suicide attempt by the Columbia-Suicide Severity Rating Scale (C-SSRS )

次要结局

  • Anxiety(At 3, 6 and 12 months after the inclusion)
  • Depressive level(At 3, 6 and 12 months after the inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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