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Biomarkers of Antidepressant Resistance (BIORESA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03118193
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : August 21, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depression Other: olfactive tests Biological: blood test Biological: Collection of faeces Device: Tissue Pulsatility imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Biomarkers of Antidepressant Resistance - BIORESA
Actual Study Start Date : June 16, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: Depressive patient
olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces
Other: olfactive tests
olfactive tests: odor identification, odor discrimination and olfactory threshold

Biological: blood test
one sample of 4mL

Biological: Collection of faeces
Collection of faeces by patient at home - optional

Device: Tissue Pulsatility imaging
Ultrasound exploration of brain pulsatility - optional

Primary Outcome Measures :
  1. metabolic print of blood [ Time Frame: 2 months ]
    Metabolome of blood

Secondary Outcome Measures :
  1. olfactive identification [ Time Frame: 2 months ]
    Olfactive response: odor identification

  2. olfactive discrimination [ Time Frame: 2 months ]
    Olfactive response: odor discrimination

  3. Olfactory threshold [ Time Frame: 2 months ]
    Olfactive response: olfactory threshold

  4. Microbiote of faeces [ Time Frame: 2 months ]
    Bacteria of faeces

  5. Maximal measures of brain pulsatility [ Time Frame: 2 months ]
    Maximal brain pulsatility

  6. Mean measures of brain pulsatility [ Time Frame: 2 months ]
    Mean brain pulsatility

  7. Metabolic print of faces [ Time Frame: 2 months ]
    Metabolome of faeces

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03118193

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Contact: Wissam El-Hage, PhD 02 47 47 37 28

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CHU Tours Recruiting
Tours, France, 37044
Contact: Wissam El-Hage, PhD   
Principal Investigator: Wissam El-Hage, PhD         
Sub-Investigator: Mathieu Lemaire, MD         
Sub-Investigator: Jean-Baptiste Courtine, MD         
Sub-Investigator: Vincent Camus, PhD         
Sub-Investigator: Thomas Desmidt, PhD         
Sub-Investigator: Valérie Gissot, MD         
Sponsors and Collaborators
University Hospital, Tours
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Principal Investigator: Wissam El-Hage, PhD CHRU TOURS
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Responsible Party: University Hospital, Tours Identifier: NCT03118193    
Other Study ID Numbers: PHAO16-WEH/BIORESA
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Tours:
Additional relevant MeSH terms:
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Behavioral Symptoms