5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression

NCT ID: NCT02876757

Last Updated: 2024-01-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186394 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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BPH Depression Suicide

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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5ARI Users

5ARI

Intervention Type DRUG

Exposure to finasteride/dutasteride

Non 5ARI users

No interventions assigned to this group

Interventions

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5ARI

Exposure to finasteride/dutasteride

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

66 Years

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2016 0906 192 000

Identifier Type: -

Identifier Source: org_study_id

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