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临床试验/NCT04137458
NCT04137458Unknown不适用

Exploration of the the Relationship Between Inflammation and Integrity of the Blood-brain Barrier in Suicidal Behaviour

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2019年11月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
105
试验地点
2
主要终点
Blood level of S100B

研究概览

简要总结

Recent studies have revealed an association between history of suicide attempt and inflammatory markers in both the cerebrospinal fluid and the plasma. Post mortem studies have shown an increase in microglial activation in the brain tissue of suicide victims. However the relationship between peripheral and central inflammation in suicide is probably mediated by complex biological processes that are yet elucidated. An increase of blood S100B levels (biomarker of neurovascular damage; PMID 14530574) has been reported in adolescents with suicidal ideation vs. controls and independently of psychiatric disorder. The investigators hypothesize that peripheral inflammation may alter BBB which normally acts as a filter to ensure proper neuronal functioning in suicidal vs. non suicidal patients.

详细描述

105 participants will be recruited :

  • 35 depressed patients having attempted suicide (maximum 3 attempts in life)
  • 35 depressed patients without history of suicide attempt (affective controls)
  • 35 healhy controls with no lifetime psychiatric history.

Only one visit is planned. A clinical assessment (2 hours) will be performed to characterise pschopathology and suicidal characteristics. Blood and salivary samples will be obtained in order to measure inflammatory markers.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-55 years old
  • Able to understand nature, aims, and methodology of the study
  • Depending on the population :
  • Current depressive episode (according to DSM-5 criteria) with a recent suicide attempt (within the 8 days before inclusion) and no more than 3 attempts in life
  • Current depressive episode (according to DSM-5 criteria) without suicide attempt
  • No psychiatric history (according to DSM-5 criteria)

排除标准

  • Inflammatory diseases or intercurrent infections, or chronic diseases such as hepatitis C or B, HIV, Alzheimer's, cancer or autoimmune disease
  • Current antibiotic or anti-inflammatory treatments
  • Refusal to participate
  • Lifetime Schizoaffective disorder or schizophrenia
  • On protective measures (guardianship or trusteeship)
  • Deprived of liberty subject (administrative decision)
  • In exclusion period for another protocol
  • Not affiliated to a social security agency
  • Unable to understand and/or answer a questionnaire
  • Pregnant or lactating women

结局指标

主要结局

Blood level of S100B

时间窗: at inclusion

Blood level of S100B measured in 3 groups (i.e. suicide attempters, affective controls, healthy controls)

次要结局

  • Salivary levels of GFAP(at inclusion)
  • Identification of general peripheral inflammation(at inclusion)
  • Determination of leukocyte signature associated with suicidal behavior and depression(at inclusion)
  • Profile of salivary interleukins(at inclusion)
  • Serum levels of glial fibrillary actin protein (GFAP)(at inclusion)
  • Serum levels of ubiquitinar-carboxy-terminal hydrolase L1 (UCH-L1)(at inclusion)
  • Profile of peripheral inflammation of each group(at inclusion)
  • Pro-inflammatory profile based on cytokins of each group(at inclusion)
  • Serum levels of specific neuronal enolase (NSE)(at inclusion)
  • Salivary levels of S100B protein(at inclusion)
  • Salivary levels of specific neuronal enolase (NSE)(at inclusion)
  • In vitro fluorescence ratio Dapi / phalloidin(at inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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