Clinical trial NCT03118193: Biomarkers of Antidepressant Resistance
Official title: Biomarkers of Antidepressant Resistance - BIORESA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: depression
antidepressant
resistance
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: metabolic print of blood
timeFrame: 2 months
Secondary outcomes:
measure: olfactive identification
timeFrame: 2 months
measure: olfactive discrimination
timeFrame: 2 months
measure: Olfactory threshold
timeFrame: 2 months
measure: Microbiote of faeces
timeFrame: 2 months
measure: Maximal measures of brain pulsatility
timeFrame: 2 months
measure: Mean measures of brain pulsatility
timeFrame: 2 months
measure: Metabolic print of faces
timeFrame: 2 months
Other outcomes:
Locations:
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHRU TOURS
name: Wissam El-Hage, PhD
role: PRINCIPAL_INVESTIGATOR
References: