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临床试验/NCT03052855
NCT03052855已完成不适用

Title: Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy.

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
2
主要终点
Glutamine (Glu) and Glutamate (Glx) levels

研究概览

简要总结

Suicidal behaviors (SB) are a major health problem in France : 10 000 suicides and 220 000 suicide attempts every year. SB management is therefore a major public health issue.

Evidence associated dysregulation of the serotonergic system and the hypothalamic-pituitary-adrenal axis to vulnerability to SB. Recent data point to linke these abnormalities with neuroinflammatory clues, glutamatergic function and neuronal plasticity. There is a need to better understand the physiopathology and develop diagnostic and therapeutic tools in SB.

The investigators hypothesize that increased peripheral biomarkers of inflammation would correlate to a disturbance of the cerebral metabolites, such as glutamate and NAA, especially in suicidal patients.

Our aim is to compare rates of cerebral metabolites, in particular the complex glutamine/glutamate, in cerebral areas involved in suicidal vulnerability (the anterior cingulate cortex and the orbito-frontal cortex) between person with unipolar disorder with and without suicidal attempt.

详细描述

69 patients : 23 with suicidal thoughts and attempt, 23 with suicidal thoughts without attempt and 23 healthy volunteers.

2 visits :

  • Inclusion visit (V0) : (Day 1)

o Clinical interview : self and hetero assessment questionnaire

  • Visit V1 (as soon as possible, day 1 if available) :

  • MRI (spectroscopy)

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 70 Years(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

Glutamine (Glu) and Glutamate (Glx) levels

时间窗: At V1 (the day of the MRI)

Levels of Glu/Glx in the anterior cingulate cortex and the orbitofrontal cortex between the depressed patients with and without suicide attempt

次要结局

  • Link between rate of Interleukin 1, 2, 4, 5, 6, 7, 9, 10, 13 and suicide attempt(At V1 (the day of the MRI))
  • Level of N-Acetyl-Aspartate (NAA)(At V1 (the day of the MRI))
  • Level of Choline (Cho)(At V1 (the day of the MRI))
  • Level of Myo-inositol (Myo)(At V1 (the day of the MRI))
  • Level of Creatinine (Cr)(At V1 (the day of the MRI))
  • Link between level of depression self assessed with the Beck Scale and metabolites levels(At V1 (the day of the MRI))
  • Link between level of suicidal intentionality assessed by the Columbia Suicide Severity Rating Scale (CSS-RS) and metabolites levels(At V1 (the day of the MRI))
  • Link between level of depression assessed by the clinician with the Hamilton Rating Scale (HAMD) and metabolite levels(At V1 (the day of the MRI))
  • Link between rate of Tumor necrosis factor alpha (TNF α) and suicide attempt(At V1 (the day of the MRI))
  • Link between rate of Tumor necrosis factor beta (TNFβ) and suicide attempt(At V1 (the day of the MRI))
  • Link between rate of Interferon gamma (IFNγ) and suicide attempt(At V1 (the day of the MRI))
  • Link between rate of C-Reactive Protein (CRP) and suicide attempt(At V1 (the day of the MRI))
  • Link between rate of Interferon Gamma Inducing Factors (IGIF)and suicide attempt(At V1 (the day of the MRI))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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