5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's186,394 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

186,394

Conditions

BPH Depression Suicide

Interventions

5ARIDRUG

Exposure to finasteride/dutasteride

Eligibility

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.