Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT03118193
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2017-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers of Antidepressant Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2017-04-10', 'studyFirstSubmitQcDate': '2017-04-14', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'metabolic print of blood', 'timeFrame': '2 months', 'description': 'Metabolome of blood'}], 'secondaryOutcomes': [{'measure': 'olfactive identification', 'timeFrame': '2 months', 'description': 'Olfactive response: odor identification'}, {'measure': 'olfactive discrimination', 'timeFrame': '2 months', 'description': 'Olfactive response: odor discrimination'}, {'measure': 'Olfactory threshold', 'timeFrame': '2 months', 'description': 'Olfactive response: olfactory threshold'}, {'measure': 'Microbiote of faeces', 'timeFrame': '2 months', 'description': 'Bacteria of faeces'}, {'measure': 'Maximal measures of brain pulsatility', 'timeFrame': '2 months', 'description': 'Maximal brain pulsatility'}, {'measure': 'Mean measures of brain pulsatility', 'timeFrame': '2 months', 'description': 'Mean brain pulsatility'}, {'measure': 'Metabolic print of faces', 'timeFrame': '2 months', 'description': 'Metabolome of faeces'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['depression', 'antidepressant', 'resistance'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '34995994', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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%).\n\nEstablishing 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).\n\nMetabolomic 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.\n\nMetabolites are derived from biological extracts (cells, tissues, serum, plasma, urine, etc.) and are detected by:\n\n* liquid or gas chromatography coupled to mass spectrometry (LC-MS, GC-MS),\n* 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* between 18-60 years-old\n* major depressive disorder, confirmed by Mini International Neuropsychiatric Interview (MINI)\n* no bipolar disorder or schizophrenia, confirmed by MINI\n* no neurological dementia disease\n* able to perform olfactive tests, i.e. no anosmia and/or allergy to odors\n* score MADRS (Montgomery AsbergDepression Rating Scale) \\>20\n* no antidepressant treatment during 14 days before inclusion\n* informed written consent\n* affiliation to a social security system\n\nExclusion Criteria:\n\n* patient who don't want any antidepressant treatment for this depressive episode\n* legal incapacity and/or any circumstances making the person unable to understand the trial features, purposes or consequences\n* participating to drug clinical study or in exclusion period of clinical study because of previous participation\n* pregnant woman"}, 'identificationModule': {'nctId': 'NCT03118193', 'acronym': 'BIORESA', 'briefTitle': 'Biomarkers of Antidepressant Resistance', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Biomarkers of Antidepressant Resistance - BIORESA', 'orgStudyIdInfo': {'id': 'PHAO16-WEH/BIORESA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Depressive patient', 'description': 'olfactive tests ; blood test ; optional: Tissue Pulsatility imaging ; optional: Collection of faeces', 'interventionNames': ['Other: olfactive tests', 'Biological: blood test', 'Biological: Collection of faeces', 'Device: Tissue Pulsatility imaging']}], 'interventions': [{'name': 'olfactive tests', 'type': 'OTHER', 'description': 'olfactive tests: odor identification, odor discrimination and olfactory threshold', 'armGroupLabels': ['Depressive patient']}, {'name': 'blood test', 'type': 'BIOLOGICAL', 'description': 'one sample of 4mL', 'armGroupLabels': ['Depressive patient']}, {'name': 'Collection of faeces', 'type': 'BIOLOGICAL', 'description': 'Collection of faeces by patient at home - optional', 'armGroupLabels': ['Depressive patient']}, {'name': 'Tissue Pulsatility imaging', 'type': 'DEVICE', 'description': 'Ultrasound exploration of brain pulsatility - optional', 'armGroupLabels': ['Depressive patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Wissam El-Hage, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU TOURS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}