Trial Outcomes & Findings for 5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression (NCT NCT02876757)
NCT ID: NCT02876757
Last Updated: 2024-01-12
Results Overview
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".
COMPLETED
186394 participants
Through study completition, an average of 18 months.
2024-01-12
Participant Flow
Participant milestones
| Measure |
5ARI Users
5ARI: Exposure to finasteride/dutasteride
|
Non 5ARI Users
|
|---|---|---|
|
Overall Study
STARTED
|
93197
|
93197
|
|
Overall Study
COMPLETED
|
93197
|
93197
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression
Baseline characteristics by cohort
| Measure |
5ARI Users
n=93197 Participants
5ARI: Exposure to finasteride/dutasteride
|
Non 5ARI Users
n=93197 Participants
Matched patients without 5ARI usage
|
Total
n=186394 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
75.5 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
75.5 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93197 Participants
n=5 Participants
|
93197 Participants
n=7 Participants
|
186394 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
93197 participants
n=5 Participants
|
93197 participants
n=7 Participants
|
186394 participants
n=5 Participants
|
|
Prior depression
|
3353 Participants
n=5 Participants
|
3353 Participants
n=7 Participants
|
6706 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completition, an average of 18 months.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".
Outcome measures
| Measure |
5ARI Users
n=93197 Participants
5ARI: Exposure to finasteride/dutasteride
|
Non 5ARI Users
n=93197 Participants
|
|---|---|---|
|
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 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Through study completition, an average of 18 months.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
Outcome measures
| Measure |
5ARI Users
n=93197 Participants
5ARI: Exposure to finasteride/dutasteride
|
Non 5ARI Users
n=93197 Participants
|
|---|---|---|
|
Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database)
|
169 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: Through study completition, an average of 18 months.Population: This population is restricted to those who had no history of depression, thus it is a subgroup of the total study population.
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)
Outcome measures
| Measure |
5ARI Users
n=89844 Participants
5ARI: Exposure to finasteride/dutasteride
|
Non 5ARI Users
n=89844 Participants
|
|---|---|---|
|
Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan)
|
1750 Participants
|
1231 Participants
|
Adverse Events
5ARI Users
Non 5ARI Users
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place