5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186,394
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 66 Years 至 120 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All men >66 years of age in Ontario between 2003-2013
排除标准
- •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.
研究组 & 干预措施
5ARI Users
干预措施: 5ARI (Drug)
结局指标
主要结局
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)
时间窗: Through study completition, an average of 18 months.
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".
次要结局
- 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.)