Biomarkers of Antidepressant Resistance
- Conditions
- Depression
- Interventions
- Other: olfactive testsBiological: blood testBiological: Collection of faecesDevice: Tissue Pulsatility imaging
- Registration Number
- NCT03118193
- Lead Sponsor
- University Hospital, Tours
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Depressive patient blood test olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces Depressive patient Collection of faeces olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces Depressive patient Tissue Pulsatility imaging olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces Depressive patient olfactive tests olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces
- Primary Outcome Measures
Name Time Method metabolic print of blood 2 months Metabolome of blood
- Secondary Outcome Measures
Name Time Method olfactive identification 2 months Olfactive response: odor identification
Mean measures of brain pulsatility 2 months Mean brain pulsatility
Olfactory threshold 2 months Olfactive response: olfactory threshold
Metabolic print of faces 2 months Metabolome of faeces
olfactive discrimination 2 months Olfactive response: odor discrimination
Maximal measures of brain pulsatility 2 months Maximal brain pulsatility
Microbiote of faeces 2 months Bacteria of faeces
Trial Locations
- Locations (1)
CHU Tours
🇫🇷Tours, France