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OpenTrials
Completed

NCT Number: NCT02876757

5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression

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.

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Key information

Age range

66 year–120 year

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5ARI

Drug

Exposure to finasteride/dutasteride

Primary outcomes

  1. 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)

    Time frame: Through study completition, an average of 18 months.

    • 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".

Secondary outcomes

  1. Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database)

    Time frame: Through study completition, an average of 18 months.

    • 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

  2. Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan)

    Time frame: Through study completition, an average of 18 months.

    • 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)

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Important dates

Study start
2003
Primary completion
2013
Study completion
2017
First posted
Aug 24, 2016
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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