Biomarkers of Antidepressant Resistance (BIORESA)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Depression

Treatments: Other: olfactive tests; Biological: Collection of faeces; Device: Tissue Pulsatility imaging; Biological: blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT03118193

PHAO16-WEH/BIORESA

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Depressive patient

Experimental group

Description:

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

Treatment:

Biological: blood test

Device: Tissue Pulsatility imaging

Biological: Collection of faeces

Other: olfactive tests