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Biomarkers of Antidepressant Resistance (BIORESA)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by University Hospital, Tours
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT03118193
First received: April 10, 2017
Last updated: June 19, 2017
Last verified: May 2017
  Purpose

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 Intervention
Depression Other: olfactive tests Biological: blood test Biological: Collection of faeces Device: Tissue Pulsatility imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Biomarkers of Antidepressant Resistance - BIORESA

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

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


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

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

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

  • Microbiote of faeces [ Time Frame: 2 months ]
    Bacteria of faeces

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

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

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


Estimated Enrollment: 50
Actual Study Start Date: June 16, 2017
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03118193

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

Locations
France
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
Investigators
Principal Investigator: Wissam El-Hage, PhD CHRU TOURS
  More Information

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03118193     History of Changes
Other Study ID Numbers: PHAO16-WEH/BIORESA
Study First Received: April 10, 2017
Last Updated: June 19, 2017
Individual Participant Data  
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:
depression
antidepressant
resistance

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 23, 2017