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

• Conditions: Aged; Antidepressive Agents; Delirium

• Registration Number: NCT05356078
• Lead Sponsor: University Hospital, Caen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-03
• Study First Submitted: 2022-01-31
• Primary Completion: 2022-02-03
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-29
• Last Update Submitted: 2022-04-29
• Study First Posted: 2022-05-02
• Last Update Posted: 2022-05-02
• Study Completion: 2022-06-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Descriptive analysis of the studied population	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	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)

Secondary Outcome Measures

Name	Time	Method
Analysis by age group	03/01/2022	Investigators study the association between antidepressant classes and delirium reporting for the age group 65-74 and for the age group 75 and over.; A disproportionality analysis is carried out in multivariate analysis, taking into account a certain number of confounding factors (co-prescriptions and comorbidities)
Analysis of the co-reporting of delirium and hyponatraemia	03/01/2022	Investigators study the association between antidepressant classes and co-reporting of delirium and hyponatraemia among subjects aged 65 or older.; A disproportionality analysis is carried out in multivariate analysis, taking into account a certain number of confounding factors (co-prescriptions and comorbidities).
Analysis of the most prescribed antidepressant	03/01/2022	Investigators study the association between most prescribed antidepressants and delirium reporting among patients aged 65 or older.; We identified most prescribed antidepressants as those with more than 1000 cases reported in VigiBase®.; A disproportionality analysis is carried out in multivariate analysis, taking into account a certain number of confounding factors (co-prescriptions and comorbidities).

Trial Locations

Locations (1)

Caen University Hospital, Department of Pharmacology; 🇫🇷 Caen, Normandie, France