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临床试验/NCT02824081
NCT02824081Unknown不适用

Neuroinflammation, Serotonin, Impulsivity and Suicide

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
280
试验地点
2
主要终点
Rate of interleukin 2 (Il2) in a blood sample

研究概览

简要总结

Suicide is a major health problem that causes annually a million death worlwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition (personality, family history of SB...) and stressful conditions (early life adversity).

Studies show that suicide ideations could favour inflammation and that depression is associated with an elevated inflammation.

Recent evidences also suggest that inflammatory mediators play a critical role in SB.

The aim of the study is to evaluate the inflammatory markers rate on depressed patients with or without personal history of SB.

In the second part of the study, the relations between the rates of inflammatory markers and characteristics of SB, impulsivity, psychological pain, childhood abuse and gene expression of 5HT2B receptor will be investigated.

详细描述

Over one year, we will recruit 280 patients suffering from a major depressive episode with (n=140) and without any history of suicide attempt (n=140), from a specialized clinic for mood disorders and SB.

First visit : clinical, biological and neuropsychological assessment

Second visit, at 6 month : Follow-up visit in the department or interview by telephone in order to assess suicidal ideations or suicide attempts since the inclusion.

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

  • Ages of 18 and 65
  • Main diagnosis of major depressive episode (DSM-IV criteria)
  • Having signed the informed consent
  • Able to understand nature, aims, and methodology of the study
  • Specifics Inclusion criteria:
  • Depressed patients with suicide attempt history :
  • Have done in his lifetime at least one suicide attempt (however the period of time between inclusion and suicide attempt)
  • Depressed patients without suicide attempt history :
  • Had never realized suicide attempt in his lifetime

排除标准

  • Patients suffering from inflammatories pathology
  • Antibiotic or anti-inflammatory current treatment
  • Pregnancy
  • Participation in another clinical trial with an exclusion period
  • Patient on protective measures (guardianship or trusteeship)

结局指标

主要结局

Rate of interleukin 2 (Il2) in a blood sample

时间窗: inclusion visit

Comparison of Il2 levels between patients with and without suicidal behaviour

次要结局

  • Relation between markers of inflammation and gene expression(inclusion visit)
  • Markers of inflammation as a risk factor for suicidal behavior(at 6 months)
  • Rate of inflammation markers and violent suicide attempt(inclusion visit)
  • Rate of inflammation markers and suicide ideations(inclusion visit)
  • Relation between markers of inflammation and impulsivity(inclusion visit)
  • Rate of inflammation markers (Interleukin 1, 4, 6, 8, 10, Tumor necrosis factor alpha (TNF-a), Interferon gamma (IFNg), Vascular endothelial growth factor (VEGF), kynurenin and c-reactive protein (CRP) in a blood sample(inclusion visit)
  • Rate of inflammation markers and suicide attempt(inclusion visit)
  • Relation between markers of inflammation and psychological pain(inclusion visit)
  • Relation between markers of inflammation and child abuse(inclusion visit)
  • Relation between markers of inflammation and suicidal behavior characteristics(inclusion visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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