5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression

NCT02876757 | Completed Results

• 1 other identifier: 2016 0906 192 000
• Study Type: observational
• Target: 186,394
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

BPH; Depression; Suicide

Outcome Measures

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)

  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".

  Through study completition, an average of 18 months.

Secondary Outcomes (2)

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

  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)

  Through study completition, an average of 18 months.

Study Arms (2)

5ARI Users

Drug: 5ARI

Non 5ARI users

Interventions

5ARI DRUG

Exposure to finasteride/dutasteride

5ARI Users

Eligibility Criteria

• Age: 66 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Depression; Suicide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Injurious Behavior

Results Point of Contact

• Title: Blayne Welk
• Organization: ICES Western

blayne.welk@sjhc.london.on.ca

5196466000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 24, 2016
• Study Start: January 1, 2003
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2017
• Last Updated: January 12, 2024
• Results First Posted: February 5, 2018

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share