Neuroinflammation, Serotonin, Impulsivity and Suicide (NISIS)
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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Montpellier、法国、34295
- 招聘中
- University Hospital
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接触：
- Catherine GENTY, MD
- 电话号码：+33 4 67 99 61 45 75
- 邮箱：c-genty@chu-montpellier.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的？
设计细节
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Depressive patients
Blood samples (inflammatory biomarkers and genetic purpose) on depressive patients with or without story of suicidal behavior
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Blood sample in order to study inflammatory biomarkers and genetics purpose
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rate of interleukin 2 (Il2) in a blood sample
大体时间：inclusion visit
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Comparison of Il2 levels between patients with and without suicidal behaviour
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inclusion visit
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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
大体时间：inclusion visit
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Comparison of the levels of theses markers between patients with and without suicidal behaviour
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inclusion visit
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Rate of inflammation markers and suicide attempt
大体时间：inclusion visit
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Comparison of rate bloodmarkers inflammation (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) in depressed patients with latest suicide attempt and depressed patients with an history of suicide attempt
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inclusion visit
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Rate of inflammation markers and violent suicide attempt
大体时间：inclusion visit
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Comparison of rate bloodmarkers inflammation (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) in depressed patients with and without violent suicide attempt
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inclusion visit
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Rate of inflammation markers and suicide ideations
大体时间：inclusion visit
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Comparison of rate bloddmarkers (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) in depressed patients with and without current suicide ideation
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inclusion visit
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Relation between markers of inflammation and suicidal behavior characteristics
大体时间：inclusion visit
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Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and suicidal behaviour characteristics (the last and the most serious) (intentionality, planification, lethality)
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inclusion visit
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Relation between markers of inflammation and impulsivity
大体时间：inclusion visit
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Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and impulsivity (by Baratt Impulsivity Scale and neuropsychological tests)
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inclusion visit
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Relation between markers of inflammation and psychological pain
大体时间：inclusion visit
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Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and psychological pain (by Likert scale)
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inclusion visit
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Relation between markers of inflammation and child abuse
大体时间：inclusion visit
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Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and child abuse
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inclusion visit
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Relation between markers of inflammation and gene expression
大体时间：inclusion visit
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Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and gene expression of 5HT2B receptor
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inclusion visit
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Markers of inflammation as a risk factor for suicidal behavior
大体时间：at 6 months
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Studying bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) as suicidal behaviour risk factor (suicide ideations and/or suicide attempt) with a 6 months follow-up.
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at 6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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