5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression

Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876757
• Other study ID #: 2016 0906 192 000
• Status: Completed
• Start date: January 2003
• Est. completion date: March 2017

Study information

• Verified date: January 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186394
• Est. completion date: March 2017
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 66 Years to 120 Years

Eligibility

Inclusion Criteria:

• All men >66 years of age in Ontario between 2003-2013

Exclusion Criteria:

• Non Ontario residents

• No prescriptions filled in prior 180 days

• Prior exposure to finasteride/dutasteride in the 2 years prior to study enrollment.

• Prescription initiated during hospital admission or ER visit.

Related Conditions & MeSH terms

• BPH
• Depression
• Depressive Disorder
• Suicide

Intervention

Drug:
• 5ARI
Exposure to finasteride/dutasteride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.; 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.; OMHRS: Discharge reason (dischreason (X90) = 2). Died from suicide. Consider admission date the date of the event.; CIHI-DAD (Consider admission date the date of the event): i. suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp="07".	Through study completition, an average of 18 months.
Secondary	Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database)	NACRS: presentation to the emergency room: ICD 10 codes X60-X84 (intentional self harm).; 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	Through study completition, an average of 18 months.
Secondary	Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan)	Any CIHI-DAD/SDS ICD 10 code, OR; Any OMRHS code Axis1_dsm4code1-19 or Axis2_dsm4code 1-7 OR; Look for any OHIP record billed by Mainspecialty = "PSYCHIATRY" with a diagnosis of depression OHIP dxcode 311, OR; =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)	Through study completition, an average of 18 months.