Biomarkers of Antidepressant Resistance

Depression Clinical Trial

— BIORESA  

Official title:

Biomarkers of Antidepressant Resistance - BIORESA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118193
• Other study ID #: PHAO16-WEH/BIORESA
• Status: Completed
• Phase: N/A
• Start date: June 16, 2017
• Est. completion date: January 12, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 12, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Other:
• olfactive tests
olfactive tests: odor identification, odor discrimination and olfactory threshold

Biological:
• blood test
one sample of 4mL
• Collection of faeces
Collection of faeces by patient at home - optional

Device:
• Tissue Pulsatility imaging
Ultrasound exploration of brain pulsatility - optional

Locations

Country	Name	City	State
France	CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metabolic print of blood	Metabolome of blood	2 months
Secondary	olfactive identification	Olfactive response: odor identification	2 months
Secondary	olfactive discrimination	Olfactive response: odor discrimination	2 months
Secondary	Olfactory threshold	Olfactive response: olfactory threshold	2 months
Secondary	Microbiote of faeces	Bacteria of faeces	2 months
Secondary	Maximal measures of brain pulsatility	Maximal brain pulsatility	2 months
Secondary	Mean measures of brain pulsatility	Mean brain pulsatility	2 months
Secondary	Metabolic print of faces	Metabolome of faeces	2 months