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临床试验/NCT02829671
NCT02829671已完成不适用

Study of Loneliness as Predictive Factor for Suicidal Behavior

University Hospital, Montpellier0 个研究点目标入组 600 人开始时间: 2016年10月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
600
主要终点
frequency of suicide attempts at one year

研究概览

简要总结

Suicide is a major health problem that causes annually a million death worldwide. Loneliness is known to be associated with suicidal ideation in minors and to be related with suicidal risk in elderly people. However little is known about this association in a middle-aged population. Loneliness is a modifiable factor with suitable psychotherapeutic measures, it is essential to improve the scientific and medical knowledge about the link between this feeling and suicide risk in a population of depressed patients in middle age.

The main objective is the study of the relationship between loneliness and the occurrence of suicidal behavior (SB) in major depressed adult population over 12 months.

The secondary objectives are:

  • Identification of risk factors (clinical, neuropsychological and biological) of the occurrence of SB within a clinical population and their interaction;
  • Identification of predictive factors (clinical, neuropsychological, biological) therapeutic response to antidepressant in the context of depression.

详细描述

This project is based on clinical, neuropsychological and biological data routinely collected in the Department of Emergency Psychiatry and Post Acute Care. This is a one year follow-up prospective study.

Over three years, 600 depressed patients will be recruited.

  • First visit (inclusion): clinical, biological and neuropsychological assessment
  • Follow up visits (3, 6 and 12 months): clinical assessment only

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

  • •Main diagnosis of major depressive disorder according to Diagnostic and Statistical Manual of Mental DisordersIV (DSM IV) Having signed informed consent Able to understand nature, aims, and methodology oh the study

排除标准

  • •Participation in another clinical trial Patient on protective measures (guardianship or trusteeship)

研究组 & 干预措施

Patients with major depressive disorders

Other

干预措施: Clinical and biological assessment (Other)

结局指标

主要结局

frequency of suicide attempts at one year

时间窗: At 12 months

frequency of suicide attempts during the 12 months follow-up depending on the intensity of the feeling of loneliness evaluated by the loneliness scale of the University of Laval (ESUL)

次要结局

  • frequency of suicide attempts during the follow up(At 3 and 6 months)
  • comorbid psychiatric disorders of Axis I(At the inclusion, 3, 6, and 12 months)
  • intensity of the depression(At the inclusion, 3, 6, and 12 months)
  • intensity of suicidal ideation(At the inclusion, 3, 6, and 12 months)
  • features of suicidal behavior(At the inclusion, 3, 6, and 12 months)
  • personal history of childhood abuse(At the inclusion, 3, 6, and 12 months)
  • lipid profile(At the inclusion)
  • intensity of psychological pain(At the inclusion, 3, 6, and 12 months)
  • thyroid function(At the inclusion)
  • inflammatory markers(At the inclusion, 3, 6, and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

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