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Biomarkers of Antidepressant Resistance (BIORESA)

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ClinicalTrials.gov Identifier: NCT03118193
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : June 20, 2017
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
Depression Other: olfactive tests Biological: blood test Biological: Collection of faeces Device: Tissue Pulsatility imaging

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

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

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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 ClinicalTrials.gov identifier (NCT number): NCT03118193

Contact: Wissam El-Hage, PhD 02 47 47 37 28 wissam.elhage@univ-tours.fr

CHU Tours Recruiting
Tours, France, 37044
Contact: Wissam El-Hage, PhD       wissam.elhage@univ-tours.fr   
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
Principal Investigator: Wissam El-Hage, PhD CHRU TOURS

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03118193     History of Changes
Other Study ID Numbers: PHAO16-WEH/BIORESA
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs