Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-04-20 @ 2:02 PM
Study NCT ID:
NCT02876757
Status:
COMPLETED
Last Update Posted:
2024-01-12
First Post:
2016-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'blayne.welk@sjhc.london.on.ca', 'phone': '5196466000', 'title': 'Blayne Welk', 'organization': 'ICES Western'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Please note that only mortality from suicide was assessed, all-cause mortality could not be determined.', 'eventGroups': [{'id': 'EG000', 'title': '5ARI Users', 'description': '5ARI: Exposure to finasteride/dutasteride', 'otherNumAtRisk': 93197, 'deathsNumAtRisk': 93197, 'otherNumAffected': 0, 'seriousNumAtRisk': 93197, 'deathsNumAffected': 160, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non 5ARI Users', 'description': 'Matched control patients with no exposure to 5ARI', 'otherNumAtRisk': 93197, 'deathsNumAtRisk': 93197, 'otherNumAffected': 0, 'seriousNumAtRisk': 93197, 'deathsNumAffected': 139, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Suicide (Based on Administrative Data Elements From Ontario Registrar General Death Database, National Ambulatory Care Reporting System, Hospital Discharge Abstracts, and Ontario Regional Mental Health Database)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93197', 'groupId': 'OG000'}, {'value': '93197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5ARI Users', 'description': '5ARI: Exposure to finasteride/dutasteride'}, {'id': 'OG001', 'title': 'Non 5ARI Users'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completition, an average of 18 months.', 'description': '1. Ontario Registrar General Death database. Use the COD\\_primary variable (used from 2003 onwards) to define suicide, based on an ICD10 code of X60-X84.\n2. NACRS: X60-84 (dx10code1-dx10code10) AND dead on arrival or death after arrival (visdisp2002 = 10 or 11). Consider admission date the date of the event.\n3. OMHRS: Discharge reason (dischreason (X90) = 2). Died from suicide. Consider admission date the date of the event.\n4. CIHI-DAD (Consider admission date the date of the event):\n\ni. suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp="07".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93197', 'groupId': 'OG000'}, {'value': '93197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5ARI Users', 'description': '5ARI: Exposure to finasteride/dutasteride'}, {'id': 'OG001', 'title': 'Non 5ARI Users'}], 'classes': [{'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completition, an average of 18 months.', 'description': '1. NACRS: presentation to the emergency room: ICD 10 codes X60-X84 (intentional self harm).\n2. OMHRS: admission with suicide ideation.\n\ni. Self injury attempts: D1A or selfinjury\\_attempt=3, 4, 5, or 6 ii. Self injury intent: D1B or selfinjury\\_intent=1 iii. Self injury considered: D1C or selfinjury\\_cons=3, 4, 5 or 6 iv. Self injury plan: D1DB or suicide\\_plan=1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89844', 'groupId': 'OG000'}, {'value': '89844', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5ARI Users', 'description': '5ARI: Exposure to finasteride/dutasteride'}, {'id': 'OG001', 'title': 'Non 5ARI Users'}], 'classes': [{'categories': [{'measurements': [{'value': '1750', 'groupId': 'OG000'}, {'value': '1231', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completition, an average of 18 months.', 'description': '1. Any CIHI-DAD/SDS ICD 10 code, OR\n2. Any OMRHS code Axis1\\_dsm4code1-19 or Axis2\\_dsm4code 1-7 OR\n3. Look for any OHIP record billed by Mainspecialty = "PSYCHIATRY" with a diagnosis of depression OHIP dxcode 311, OR\n4. ≥2 GP visits within 2 years AND both with OHIP dxcode 311\n\ni. OHIP dxcode: 311 ii. ICD 10: F32.0, F32.1, F32.2, F32.3, F32.8, F32.9, F33.0, F33.1, F33.2, F33.3, F33.4, F33.8, F34.1 iii. Psychiatry visits defined as any of these OHIP fee codes: A195, A895, A190, A795, A695, A395, A196, A193, A194, A191, A192 iv. OMHRS: 29620-29626, 29630-29636, 31100 (major depressive disorder)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This population is restricted to those who had no history of depression, thus it is a subgroup of the total study population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5ARI Users', 'description': '5ARI: Exposure to finasteride/dutasteride'}, {'id': 'FG001', 'title': 'Non 5ARI Users'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93197'}, {'groupId': 'FG001', 'numSubjects': '93197'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93197'}, {'groupId': 'FG001', 'numSubjects': '93197'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93197', 'groupId': 'BG000'}, {'value': '93197', 'groupId': 'BG001'}, {'value': '186394', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '5ARI Users', 'description': '5ARI: Exposure to finasteride/dutasteride'}, {'id': 'BG001', 'title': 'Non 5ARI Users', 'description': 'Matched patients without 5ARI usage'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.6', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '75.5', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '75.5', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '93197', 'groupId': 'BG000'}, {'value': '93197', 'groupId': 'BG001'}, {'value': '186394', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '93197', 'groupId': 'BG000'}, {'value': '93197', 'groupId': 'BG001'}, {'value': '186394', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior depression', 'classes': [{'categories': [{'measurements': [{'value': '3353', 'groupId': 'BG000'}, {'value': '3353', 'groupId': 'BG001'}, {'value': '6706', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186394}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2016-08-05', 'resultsFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2016-08-18', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-19', 'studyFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suicide (Based on Administrative Data Elements From Ontario Registrar General Death Database, National Ambulatory Care Reporting System, Hospital Discharge Abstracts, and Ontario Regional Mental Health Database)', 'timeFrame': 'Through study completition, an average of 18 months.', 'description': '1. Ontario Registrar General Death database. Use the COD\\_primary variable (used from 2003 onwards) to define suicide, based on an ICD10 code of X60-X84.\n2. NACRS: X60-84 (dx10code1-dx10code10) AND dead on arrival or death after arrival (visdisp2002 = 10 or 11). Consider admission date the date of the event.\n3. OMHRS: Discharge reason (dischreason (X90) = 2). Died from suicide. Consider admission date the date of the event.\n4. CIHI-DAD (Consider admission date the date of the event):\n\ni. suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp="07".'}], 'secondaryOutcomes': [{'measure': 'Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database)', 'timeFrame': 'Through study completition, an average of 18 months.', 'description': '1. NACRS: presentation to the emergency room: ICD 10 codes X60-X84 (intentional self harm).\n2. OMHRS: admission with suicide ideation.\n\ni. Self injury attempts: D1A or selfinjury\\_attempt=3, 4, 5, or 6 ii. Self injury intent: D1B or selfinjury\\_intent=1 iii. Self injury considered: D1C or selfinjury\\_cons=3, 4, 5 or 6 iv. Self injury plan: D1DB or suicide\\_plan=1'}, {'measure': 'Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan)', 'timeFrame': 'Through study completition, an average of 18 months.', 'description': '1. Any CIHI-DAD/SDS ICD 10 code, OR\n2. Any OMRHS code Axis1\\_dsm4code1-19 or Axis2\\_dsm4code 1-7 OR\n3. Look for any OHIP record billed by Mainspecialty = "PSYCHIATRY" with a diagnosis of depression OHIP dxcode 311, OR\n4. ≥2 GP visits within 2 years AND both with OHIP dxcode 311\n\ni. OHIP dxcode: 311 ii. ICD 10: F32.0, F32.1, F32.2, F32.3, F32.8, F32.9, F33.0, F33.1, F33.2, F33.3, F33.4, F33.8, F34.1 iii. Psychiatry visits defined as any of these OHIP fee codes: A195, A895, A190, A795, A695, A395, A196, A193, A194, A191, A192 iv. OMHRS: 29620-29626, 29630-29636, 31100 (major depressive disorder)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['BPH', 'Depression', 'Suicide']}, 'descriptionModule': {'briefSummary': 'In December 2015, Health Canada issued a warning about a potential relationship between suicide and finasteride use and called for further research. No population based studies have assessed the risk of suicide with finasteride use, and this risk is not currently part of the product monograph. Furthermore, the link between depression and finasteride has not been well studied in the older population who are the primary users of this medication.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '66 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All men \\>66 years of age in Ontario between 2003-2013', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All men \\>66 years of age in Ontario between 2003-2013\n\nExclusion Criteria:\n\n* Non Ontario residents\n* No prescriptions filled in prior 180 days\n* Prior exposure to finasteride/dutasteride in the 2 years prior to study enrollment.\n* Prescription initiated during hospital admission or ER visit.'}, 'identificationModule': {'nctId': 'NCT02876757', 'briefTitle': '5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'orgStudyIdInfo': {'id': '2016 0906 192 000'}}, 'armsInterventionsModule': {'armGroups': [{'label': '5ARI Users', 'interventionNames': ['Drug: 5ARI']}, {'label': 'Non 5ARI users'}], 'interventions': [{'name': '5ARI', 'type': 'DRUG', 'description': 'Exposure to finasteride/dutasteride', 'armGroupLabels': ['5ARI Users']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}