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Biomarkers of Antidepressant Resistance

Biomarkers of Antidepressant Resistance - BIORESA

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03118193
Acronym
BIORESA
Enrollment
50
Registered
2017-04-18
Start date
2017-06-16
Completion date
2021-01-12
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

depression, antidepressant, resistance

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.

Interventions

OTHERolfactive tests

olfactive tests: odor identification, odor discrimination and olfactory threshold

BIOLOGICALblood test

one sample of 4mL

BIOLOGICALCollection of faeces

Collection of faeces by patient at home - optional

DEVICETissue Pulsatility imaging

Ultrasound exploration of brain pulsatility - optional

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
metabolic print of blood2 monthsMetabolome of blood

Secondary

MeasureTime frameDescription
olfactive discrimination2 monthsOlfactive response: odor discrimination
Olfactory threshold2 monthsOlfactive response: olfactory threshold
Microbiote of faeces2 monthsBacteria of faeces
olfactive identification2 monthsOlfactive response: odor identification
Mean measures of brain pulsatility2 monthsMean brain pulsatility
Metabolic print of faces2 monthsMetabolome of faeces
Maximal measures of brain pulsatility2 monthsMaximal brain pulsatility

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026