An observational study in BPH, Depression and Suicide, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Completed. Open to male participants aged 66 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Observational
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 186,394 is above the median of 160 across 1,084 observational studies indexed under Depression.
Browse Depression studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All men >66 years of age in Ontario between 2003-2013
Exclusion Criteria:
Drug: 5ARI
Exposure to finasteride/dutasteride
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)
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. 2. 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. 3. OMHRS: Discharge reason (dischreason (X90) = 2). Died from suicide. Consider admission date the date of the event. 4. CIHI-DAD (Consider admission date the date of the event): i. suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp="07".
Time frame: Through study completition, an average of 18 months.
Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database)
1. NACRS: presentation to the emergency room: ICD 10 codes X60-X84 (intentional self harm). 2. OMHRS: admission with suicide ideation. i. 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
Time frame: Through study completition, an average of 18 months.
Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan)
1. Any CIHI-DAD/SDS ICD 10 code, OR 2. Any OMRHS code Axis1_dsm4code1-19 or Axis2_dsm4code 1-7 OR 3. Look for any OHIP record billed by Mainspecialty = "PSYCHIATRY" with a diagnosis of depression OHIP dxcode 311, OR 4. ≥2 GP visits within 2 years AND both with OHIP dxcode 311 i. 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)
Time frame: Through study completition, an average of 18 months.
| Milestone | 5ARI Users | Non 5ARI Users |
|---|---|---|
| Started | 93197 | 93197 |
| Completed | 93197 | 93197 |
| Not completed | 0 | 0 |
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. 2. 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. 3. OMHRS: Discharge reason (dischreason (X90) = 2). Died from suicide. Consider admission date the date of the event. 4. CIHI-DAD (Consider admission date the date of the event): i. suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp="07".
| Participants | 5ARI Users | Non 5ARI Users |
|---|---|---|
| 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) | 38 | 36 |
1. NACRS: presentation to the emergency room: ICD 10 codes X60-X84 (intentional self harm). 2. OMHRS: admission with suicide ideation. i. 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
| Participants | 5ARI Users | Non 5ARI Users |
|---|---|---|
| Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database) | 169 | 130 |
1. Any CIHI-DAD/SDS ICD 10 code, OR 2. Any OMRHS code Axis1_dsm4code1-19 or Axis2_dsm4code 1-7 OR 3. Look for any OHIP record billed by Mainspecialty = "PSYCHIATRY" with a diagnosis of depression OHIP dxcode 311, OR 4. ≥2 GP visits within 2 years AND both with OHIP dxcode 311 i. 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)
| Participants | 5ARI Users | Non 5ARI Users |
|---|---|---|
| Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan) | 1750 | 1231 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 5ARI Users | 160/93,197 (0.2%) | 0/93,197 (0%) | 0/93,197 (0%) |
| Non 5ARI Users | 139/93,197 (0.1%) | 0/93,197 (0%) | 0/93,197 (0%) |
| Age, Continuous(years) | 5ARI Users | Non 5ARI Users | Total |
|---|---|---|---|
| Mean | 75.6 ± 6.7 | 75.5 ± 6.9 | 75.5 ± 6.8 |
| Sex: Female, Male(Participants) | 5ARI Users | Non 5ARI Users | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 93197 | 93197 | 186394 |
| Region of Enrollment(participants) | 5ARI Users | Non 5ARI Users | Total |
|---|---|---|---|
| Canada | 93197 | 93197 | 186394 |
| Prior depression(Participants) | 5ARI Users | Non 5ARI Users | Total |
|---|---|---|---|
| Count of participants | 3353 | 3353 | 6706 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's