Biomarkers of Antidepressant Resistance

Study Overview
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Brief Summary
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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.

Official Title
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Biomarkers of Antidepressant Resistance - BIORESA

Conditions
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Depression

Intervention / Treatment
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* Other: olfactive tests
* Biological: blood test
* Biological: Collection of faeces
* Device: Tissue Pulsatility imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Depressive patient<br>olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces | Other: olfactive tests<br>* olfactive tests: odor identification, odor discrimination and olfactory threshold<br>Biological: blood test<br>* one sample of 4mL<br>Biological: Collection of faeces<br>* Collection of faeces by patient at home - optional<br>Device: Tissue Pulsatility imaging<br>* Ultrasound exploration of brain pulsatility - optional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic print of blood | Metabolome of blood | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| olfactive identification | Olfactive response: odor identification | 2 months | 
| olfactive discrimination | Olfactive response: odor discrimination | 2 months | 
| Olfactory threshold | Olfactive response: olfactory threshold | 2 months | 
| Microbiote of faeces | Bacteria of faeces | 2 months | 
| Maximal measures of brain pulsatility | Maximal brain pulsatility | 2 months | 
| Mean measures of brain pulsatility | Mean brain pulsatility | 2 months | 
| Metabolic print of faces | Metabolome of faeces | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, antidepressant, resistance