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临床试验/NCT05356078
NCT05356078Unknown不适用

Association Between Prescription of Antidepressants and Delirium in the Elderly : Analysis From the World Health Organization Global Database

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2022年1月3日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
10,000
试验地点
1
主要终点
Descriptive analysis of the studied population

研究概览

简要总结

Delirium is a frequent reason for hospitalisation of the elderly. Associations between the prescription of some medicines and the risk of delirium have already been demonstrated.

Antidepressants are widely prescribed in the elderly because of the frequency of anxiety-depressive symptoms in this population, where there are high pharmacokinetic and pharmacodynamic variability.

However, the association between antidepressants and the risk of delirium remains poorly understood.

Based on the analysis from the World Health Organization global database, the main objective of this study is to investigate the association between the different classes of antidepressants and the occurrence of the " delirium " event reported in the database.

A disproportionality analysis will be performed. It will aim to assess whether some classes of antidepressants, and within these classes some molecules, are associated with a greater risk of delirium.

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
65 Years 至 120 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • be over 65 years old
  • taking antidepressants
  • to have presented delirium

排除标准

  • 未提供

结局指标

主要结局

Descriptive analysis of the studied population

时间窗: 03/01/2022

From the WORLD HEALTH ORGANIZATION Vigibase pharmacovigilance database, the investigators select all patients over 65 years old. Then among them, the investigators report : * Antidepressants use by class (Non-selective monoamine reuptake inhibitors, Selective serotonin reuptake inhibitors, Selective serotonin-norepinephrine reuptake Inhibitors, Alpha-2-adrenergic receptor antagonists, Monoamine oxidase inhibitors, other antidepressants) * Delirium event * Co-prescription (Opioids, Antipsychotics, Anxiolytics, Hynotics) * Comorbidities (Constipation, acute retention of urine, hyponatraemia etc...)

Analysis of the association between antidepressant classes and delirium reporting, among subjects aged 65 or older

时间窗: 03/01/2022

A disproportionality analysis is carried out in multivariate analysis, taking into account a certain number of confounding factors (co-prescriptions and comorbidities)

次要结局

  • Analysis by age group(03/01/2022)
  • Analysis of the co-reporting of delirium and hyponatraemia(03/01/2022)
  • Analysis of the most prescribed antidepressant(03/01/2022)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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