Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2017-06-16
2021-01-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Depressive patient
olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces
olfactive tests
olfactive tests: odor identification, odor discrimination and olfactory threshold
blood test
one sample of 4mL
Collection of faeces
Collection of faeces by patient at home - optional
Tissue Pulsatility imaging
Ultrasound exploration of brain pulsatility - optional
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
olfactive tests
olfactive tests: odor identification, odor discrimination and olfactory threshold
blood test
one sample of 4mL
Collection of faeces
Collection of faeces by patient at home - optional
Tissue Pulsatility imaging
Ultrasound exploration of brain pulsatility - optional
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Tours
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wissam El-Hage, PhD
Role: PRINCIPAL_INVESTIGATOR
CHRU TOURS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Tours
Tours, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PHAO16-WEH/BIORESA
Identifier Type: -
Identifier Source: org_study_id