National Multicentric Study on the Predictive Factors for Suicidal Behavior During a Major Depressive Episode
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 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
- 否
入选标准
- •>18 years old
- •Diagnostic Statistical Manuel IV (DSM IV) criteria for major depressive episode (
- •Subject signs a non-opposition form
- •Able to understand the nature, purpose and methodology of the study
- •Affiliated with a French social security agency
- •Not planning to change residence within 12 months
- •Available by phone and / or email
- •Specific inclusion criteria for the suicide group:
- •Admission to the hospital within 48 hours of the last suicide attempt.
- •Specific inclusion criteria for emotional control group:
- •No history of lifetime suicide attempt suicide.
排除标准
- •Patients hospitalized for more than 7 days
- •Refusal to participate
- •Individual deprived of freedom (by judicial or administrative decision)
- •Individual protected by law (guardianship)
- •Subject to exclusion period in another protocol
- •Not affiliated to a social security agency
研究组 & 干预措施
Depressed patients
Depressed patients with a recent suicide attempt or without any personal history of suicide attempt
干预措施: Standardized assessment on depressed patients (Other)
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
- Depressive level(At 3, 6 and 12 months after the inclusion)
- Anxiety(At 3, 6 and 12 months after the inclusion)