DepressionBIORESANCT03118193
Biomarkers of Antidepressant Resistance
A study testing olfactive tests, blood test and Collection of faeces in people with Depression, run by University Hospital, Tours at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- olfactive tests, blood test and Collection of faeces
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2017to 12 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- no antidepressant treatment during 14 days before inclusion
- informed written consent
- affiliation to a social security system
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers of Antidepressant Resistance - BIORESA
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).
Read more
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.
- Conditions
- Depression
- Being tested
- olfactive tests, blood test, Collection of faeces, Tissue Pulsatility imaging
- Keywords
- depression, antidepressant, resistance
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactive testsOther
olfactive tests: odor identification, odor discrimination and olfactory threshold
blood testBiological
one sample of 4mL
Collection of faecesBiological
Collection of faeces by patient at home - optional
Tissue Pulsatility imagingDevice
Ultrasound exploration of brain pulsatility - optional
| Study group | Role | What they receive |
|---|---|---|
| Depressive patient | Experimental | olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces Receives: Other: olfactive tests; Biological: blood test; Biological: Collection of faeces; Device: Tissue Pulsatility imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic print of blood
Metabolome of blood
Measured: 2 months
Secondary outcomes (7)
olfactive identification
Olfactive response: odor identification
Measured: 2 months
olfactive discrimination
Olfactive response: odor discrimination
Measured: 2 months
Olfactory threshold
Olfactive response: olfactory threshold
Measured: 2 months
Microbiote of faeces
Bacteria of faeces
Measured: 2 months
Maximal measures of brain pulsatility
Maximal brain pulsatility
Measured: 2 months
Mean measures of brain pulsatility
Mean brain pulsatility
Measured: 2 months
Metabolic print of faces
Metabolome of faeces
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start16 Jun 2017
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wissam El-Hage, PhD, Principal investigator, CHRU TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118193
- Sponsor's protocol ID
- PHAO16-WEH/BIORESA
- Acronym
- BIORESA
- Status last verified
- Dec 2025
- First submitted
- 10 Apr 2017
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desmidt T, Dujardin PA, Brizard B, Remenieras JP, Gissot V, Dufour-Rainfray D, Atanasova B, Kazour F, Belzung C, Camus V, El-Hage W. Decrease in ultrasound Brain Tissue Pulsations as a potential surrogate marker of response to antidepressant. J Psychiatr Res. 2022 Feb;146:186-191. doi: 10.1016/j.jpsychires.2021.12.056. Epub 2022 Jan 3.
PubMed 34995994
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Antidepressant Resistance - BIORESA
- ClinicalTrials.gov ID
- NCT03118193
- Acronym / sponsor ID
- BIORESA / PHAO16-WEH/BIORESA
- Conditions
- Depression
- Keywords
- depression, antidepressant, resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depressive patient | Experimental | Other: olfactive tests, Biological: blood test, Biological: Collection of faeces, Device: Tissue Pulsatility imagingolfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olfactive testsolfactive tests: odor identification, odor discrimination and olfactory threshold | Other | Depressive patient |
| blood testone sample of 4mL | Biological | Depressive patient |
| Collection of faecesCollection of faeces by patient at home - optional | Biological | Depressive patient |
| Tissue Pulsatility imagingUltrasound exploration of brain pulsatility - optional | Device | Depressive patient |
Primary outcome
metabolic print of blood
Time frame: 2 months
Metabolome of blood
7 secondary outcomes
olfactive identification
Time frame: 2 months
olfactive discrimination
Time frame: 2 months
Olfactory threshold
Time frame: 2 months
Microbiote of faeces
Time frame: 2 months
Maximal measures of brain pulsatility
Time frame: 2 months
Mean measures of brain pulsatility
Time frame: 2 months
Metabolic print of faces
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Results publication: PubMed 34995994Desmidt T, Dujardin PA, Brizard B, Remenieras JP, Gissot V, Dufour-Rainfray D, Atanasova B, Kazour F, Belzung C, Camus V, El-Hage W. Decrease in ultrasound Brain Tissue Pulsations as a potential surrogate marker of response to antidepressant. J Psychiatr Res. 2022 Feb;146:186-191. doi: 10.1016/j.jpsychires.2021.12.056. Epub 2022 Jan 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wissam El-Hage, PhD principal investigator
CHRU TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olfactive tests, blood test and Collection of faeces in people with Depression, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolic print of blood (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03118193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.