NCT03118193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2021

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

3.6 years

First QC Date

April 10, 2017

Last Update Submit

December 16, 2025

Conditions

Depression

Keywords

depressionantidepressantresistance

Outcome Measures

Primary Outcomes (1)

  • metabolic print of blood

    Metabolome of blood

    2 months

Secondary Outcomes (7)

  • olfactive identification

    2 months

  • olfactive discrimination

    2 months

  • Olfactory threshold

    2 months

  • Microbiote of faeces

    2 months

  • Maximal measures of brain pulsatility

    2 months

  • +2 more secondary outcomes

Study Arms (1)

Depressive patient

EXPERIMENTAL

olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces

Other: olfactive testsBiological: blood testBiological: Collection of faecesDevice: Tissue Pulsatility imaging

Interventions

olfactive testsOTHER

olfactive tests: odor identification, odor discrimination and olfactory threshold

Depressive patient
blood testBIOLOGICAL

one sample of 4mL

Depressive patient
Collection of faecesBIOLOGICAL

Collection of faeces by patient at home - optional

Depressive patient
Tissue Pulsatility imagingDEVICE

Ultrasound exploration of brain pulsatility - optional

Depressive patient

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • informed written consent
  • affiliation to a social security system

You may not qualify if:

  • 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
  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Tours

Tours, 37044, France

Location

Related Publications (1)

  • 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.

    PMID: 34995994RESULT

MeSH Terms

Conditions

Depression

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Wissam El-Hage, PhD

    CHRU TOURS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 18, 2017

Study Start

June 16, 2017

Primary Completion

January 12, 2021

Study Completion

January 12, 2021

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)