Biomarkers of Antidepressant Resistance (BIORESA)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
olfactive tests
blood test
Collection of faeces
Tissue Pulsatility imaging
Sponsored by

About this trial
This is an interventional diagnostic trial for Depression focused on measuring depression, antidepressant, resistance
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
Sites / Locations
- CHU Tours
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Depressive patient
Arm Description
olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces
Outcomes
Primary Outcome Measures
metabolic print of blood
Metabolome of blood
Secondary Outcome Measures
olfactive identification
Olfactive response: odor identification
olfactive discrimination
Olfactive response: odor discrimination
Olfactory threshold
Olfactive response: olfactory threshold
Microbiote of faeces
Bacteria of faeces
Maximal measures of brain pulsatility
Maximal brain pulsatility
Mean measures of brain pulsatility
Mean brain pulsatility
Metabolic print of faces
Metabolome of faeces
Full Information
NCT ID
NCT03118193
First Posted
April 10, 2017
Last Updated
April 29, 2021
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT03118193
Brief Title
Biomarkers of Antidepressant Resistance
Acronym
BIORESA
Official Title
Biomarkers of Antidepressant Resistance - BIORESA
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
January 12, 2021 (Actual)
Study Completion Date
January 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, antidepressant, resistance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Depressive patient
Arm Type
Experimental
Arm Description
olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces
Intervention Type
Other
Intervention Name(s)
olfactive tests
Intervention Description
olfactive tests: odor identification, odor discrimination and olfactory threshold
Intervention Type
Biological
Intervention Name(s)
blood test
Intervention Description
one sample of 4mL
Intervention Type
Biological
Intervention Name(s)
Collection of faeces
Intervention Description
Collection of faeces by patient at home - optional
Intervention Type
Device
Intervention Name(s)
Tissue Pulsatility imaging
Intervention Description
Ultrasound exploration of brain pulsatility - optional
Primary Outcome Measure Information:
Title
metabolic print of blood
Description
Metabolome of blood
Time Frame
2 months
Secondary Outcome Measure Information:
Title
olfactive identification
Description
Olfactive response: odor identification
Time Frame
2 months
Title
olfactive discrimination
Description
Olfactive response: odor discrimination
Time Frame
2 months
Title
Olfactory threshold
Description
Olfactive response: olfactory threshold
Time Frame
2 months
Title
Microbiote of faeces
Description
Bacteria of faeces
Time Frame
2 months
Title
Maximal measures of brain pulsatility
Description
Maximal brain pulsatility
Time Frame
2 months
Title
Mean measures of brain pulsatility
Description
Mean brain pulsatility
Time Frame
2 months
Title
Metabolic print of faces
Description
Metabolome of faeces
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wissam El-Hage, PhD
Organizational Affiliation
CHRU TOURS
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Biomarkers of Antidepressant Resistance
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