Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-29 @ 3:42 AM
Study NCT ID:
NCT04565834
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2020-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Genetic Alterations Affecting the Genes Encoding the Major Enzymes of the Kynurenine Pathway on Suicidal Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020641', 'term': 'Polymorphism, Single Nucleotide'}, {'id': 'D005838', 'term': 'Genotype'}], 'ancestors': [{'id': 'D011110', 'term': 'Polymorphism, Genetic'}, {'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'These are biological samples collected from previous registered studies (SUI-PREDICT, SMART CRISIS, SPAD) as well as samples from the Human Molecular Genetics Laboratory A-209 from the Faculty of Biology at the Independent University of Madrid, Spain.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 849}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2020-09-14', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age of subjects', 'timeFrame': '24 months', 'description': 'The age will be recorded for statistical purposes'}, {'measure': 'Gender of subjects', 'timeFrame': '24 months', 'description': 'The gender will be recorded for statistical purposes'}, {'measure': 'Marital status of subjects', 'timeFrame': '24 months', 'description': 'The marital status will be recorded as a number and a percentage'}, {'measure': 'Education level of subjects', 'timeFrame': '24 months', 'description': 'the education level will be recorded as a number and a percentage'}, {'measure': 'Diagnosis', 'timeFrame': '24 months', 'description': 'The diagnosis will be recorded as a number and a percentage'}, {'measure': 'Number of suicide attempts', 'timeFrame': '24 months', 'description': 'The number of suicide attempts will be recorded as a number'}, {'measure': 'Age of first suicide attempt', 'timeFrame': '24 months', 'description': 'Age of first suicide attempt will be recorded as a number'}], 'primaryOutcomes': [{'measure': 'The genotypic and allelelic frequencies of IDO1 rs7820268 SNP in each studied group', 'timeFrame': '24 months', 'description': 'The frequencies of this SNP will be measured as a percentage'}, {'measure': 'The genotypic and allelelic frequencies of IDO2 rs10109853 SNP in each studied group', 'timeFrame': '24 months', 'description': 'The frequencies of this SNP will be measured as a percentage'}, {'measure': 'The genotypic and allelelic frequencies of KMO rs1053230 SNP in each studied group', 'timeFrame': '24 months', 'description': 'The frequencies of this SNP will be measured as a percentage'}, {'measure': 'The genotypic and allelelic frequencies of KAT1 rs10988134 SNP in each studied group', 'timeFrame': '24 months', 'description': 'The frequencies of this SNP will be measured as a percentage'}, {'measure': 'The genotypic and allelelic frequencies of ACMSD rs2121337 SNP in each studied group', 'timeFrame': '24 months', 'description': 'The frequencies of this SNP will be measured as a percentage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sucidal behavior', 'Inflammation', 'Kynurenines'], 'conditions': ['Tryptophan Metabolism Alterations', 'Polymorphism', 'Suicidal Behavior']}, 'descriptionModule': {'briefSummary': 'Current research has shown that an imbalance in the Kynurenine pathway plays a role in the physiopathology of neurogenerative and mental disorders (with a decrease in neuroprotective metabolites and an increase in neurotoxic products). So far the research has concentrated on the enzymes IDO 1/2, KAT (1-4), KMO and ACMSD which are the key players in this pathway. Several polymorphisms affecting these enzymes have been associated with certain disorders characterized by a deregulation of the inflammation and immune response (McCauley et al 2009,Tardito et al 2013, Lee et al 2014), but the link between these enzymes and suicidal behavior is not yet clear. The investigators hypothesize that people with history of suicide attempt would have a genetic alterations of the kynurenine pathway specific for suicidal behavior.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients for whom biological samples have been collected and registered in the hospital's databank for the purpose of previously registered studies : SPAD (RCB no. 2016-A01375-46), SMART-CRISIS (RCB no.: 2017-A02634-49) and SUI-PREDICT (RCB no.: 2016-A00845-46) and several studies conducted at the university hospitals of Puerta de Hierro, Ramon y Cajal et Fundacion Jiminez Diaz in Madrid, Spain, since 2004.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For the "Sucide attempters" group: Any patient aged 18 or over who has made at least one suicide attempt.\n* For the two control groups: Any patient aged 18 or over, suffering from depression but has never attempted to commit suicide and any healthy subject who has never had any mental disorders.\n\nExclusion Criteria:\n\n* Any patient who has expressed opposition to the use of his/her data.'}, 'identificationModule': {'nctId': 'NCT04565834', 'acronym': 'SuiKYN', 'briefTitle': 'Effect of Genetic Alterations Affecting the Genes Encoding the Major Enzymes of the Kynurenine Pathway on Suicidal Behavior', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Étude Des Altérations Génétiques (polymorphismes) Des Gènes-clés De La Voie Kynurénine Sur Le Comportement Suicidaire', 'orgStudyIdInfo': {'id': 'NIMAO/2019-2/JLC-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': ': Suicide attempters', 'description': '325 patients who have made at least one attempt to commit suicide.', 'interventionNames': ['Genetic: SNP (single nucleotide polymorphism) genotyping']}, {'label': 'Depressed non-attempters', 'description': '99 patients suffering from depression but have never attempted to commit suicide.', 'interventionNames': ['Genetic: SNP (single nucleotide polymorphism) genotyping']}, {'label': 'Healthy controls', 'description': '425 healthy subjects (i.e. those who have no mental disorders and have never attempted to commit suicide)', 'interventionNames': ['Genetic: SNP (single nucleotide polymorphism) genotyping']}], 'interventions': [{'name': 'SNP (single nucleotide polymorphism) genotyping', 'type': 'GENETIC', 'otherNames': ['Determination of allelic and genotypic frequencies of IDO1 rs7820268, IDO2 rs10109853, KMO rs1053230, KAT1 rs10988134 and ACMSD rs2121337 SNPs in each group'], 'description': 'We use TaqMan technique to perform SNP genotyping. The PCR reactions are carried out using the Roche "Light Cycler 480" thermal cycler following the protocol recommended by Thermo Fisher Scientific. Then, replication of 10% of the samples is carried out.', 'armGroupLabels': [': Suicide attempters', 'Depressed non-attempters', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'Department of Psychiatry, Nimes University Hospital', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '28049', 'city': 'Madrid', 'country': 'Spain', 'facility': 'José-Fernandez-Piqueras', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Autonoma de Madrid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}