Biomarkers of Antidepressant Resistance | NCT03118193

Studies
Biomarkers of Antidepressant Resistance

NCT03118193

Sponsor

University Hospital, Tours

Status

Completed

Last Update Posted

Dec 23, 2025Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Depression

Interventions

olfactive tests
blood test
Collection of faeces
Tissue Pulsatility imaging

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2017Actual

Primary Completion Date

Jan 12, 2021Actual

Completion Date

Jan 12, 2021Actual

First Submitted Date

Apr 10, 2017

First Submission Date that Met QC Criteria

Apr 14, 2017

First Posted Date

Apr 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Depressive patient	Experimental	olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces	Other: olfactive tests Biological: blood test Biological: Collection of faeces Device: Tissue Pulsatility imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
olfactive tests	Other	olfactive tests: odor identification, odor discrimination and olfactory threshold	Depressive patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
metabolic print of blood	Metabolome of blood	2 months

Secondary Outcomes

Measure	Description	Time Frame
olfactive identification	Olfactive response: odor identification	2 months
olfactive discrimination	Olfactive response: odor discrimination

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wissam El-Hage, PhD	CHRU TOURS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Tours		Tours		37044	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34995994	Result	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.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques