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临床试验/NCT03118193
NCT03118193已完成不适用

Biomarkers of Antidepressant Resistance - BIORESA

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年6月16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
50
试验地点
1
主要终点
metabolic print of blood

研究概览

简要总结

According to the WHO, major depressive disorders have become the second worldwide cause of disability. Treatment, long-term medication, leads to frequent resistance (up to 40%).

Establishing a cerebral molecular signature of depression is not feasible in humans (need for cerebral samples). The alternative is to use peripheral biological samples (blood, urine, saliva).

Metabolomic is the integrated and quantitative study of all the metabolites of a biological system. This aims to define the metabolic status of an organism for a particular condition.

Metabolites are derived from biological extracts (cells, tissues, serum, plasma, urine, etc.) and are detected by:

  • liquid or gas chromatography coupled to mass spectrometry (LC-MS, GC-MS),
  • proton nuclear magnetic resonance (1 H-NMR). The biomarkers resulting from these studies have become important diagnostic criteria, measured objectively and evaluated as indicators of a normal or pathological state, or even predictors of treatment efficacy.

This approach allows the discovery of biomarkers that best describe the status of a disease for better understanding and are usable in a context of individualized medicine, with effects on clinical practice and management.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • between 18-60 years-old
  • major depressive disorder, confirmed by Mini International Neuropsychiatric Interview (MINI)
  • no bipolar disorder or schizophrenia, confirmed by MINI
  • no neurological dementia disease
  • able to perform olfactive tests, i.e. no anosmia and/or allergy to odors
  • score MADRS (Montgomery AsbergDepression Rating Scale) >20
  • no antidepressant treatment during 14 days before inclusion
  • informed written consent
  • affiliation to a social security system

排除标准

  • patient who don't want any antidepressant treatment for this depressive episode
  • legal incapacity and/or any circumstances making the person unable to understand the trial features, purposes or consequences
  • participating to drug clinical study or in exclusion period of clinical study because of previous participation
  • pregnant woman

研究组 & 干预措施

Depressive patient

Experimental

olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces

干预措施: Collection of faeces (Biological)

Depressive patient

Experimental

olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces

干预措施: olfactive tests (Other)

Depressive patient

Experimental

olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces

干预措施: blood test (Biological)

Depressive patient

Experimental

olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces

干预措施: Tissue Pulsatility imaging (Device)

结局指标

主要结局

metabolic print of blood

时间窗: 2 months

Metabolome of blood

次要结局

  • olfactive discrimination(2 months)
  • olfactive identification(2 months)
  • Mean measures of brain pulsatility(2 months)
  • Olfactory threshold(2 months)
  • Metabolic print of faces(2 months)
  • Maximal measures of brain pulsatility(2 months)
  • Microbiote of faeces(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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