Biomarkers of Antidepressant Resistance - BIORESA
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
- 否
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
olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces
干预措施: Collection of faeces (Biological)
Depressive patient
olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces
干预措施: olfactive tests (Other)
Depressive patient
olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces
干预措施: blood test (Biological)
Depressive patient
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)
