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OpenTrials
Completed

NCT Number: NCT03118193

Biomarkers of Antidepressant Resistance

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Tours

Tours, 37044, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olfactive tests

Other

olfactive tests: odor identification, odor discrimination and olfactory threshold

blood test

Biological

one sample of 4mL

Collection of faeces

Biological

Collection of faeces by patient at home - optional

Tissue Pulsatility imaging

Device

Ultrasound exploration of brain pulsatility - optional

Primary outcomes

  1. metabolic print of blood

    Time frame: 2 months

    Metabolome of blood

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Biomarkers of Antidepressant Resistance - BIORESA

Acronym: BIORESA

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 18, 2017
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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