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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05356078
• Other study ID #: Pharmaco20220103
• Status: Active, not recruiting
• Start date: January 3, 2022
• Est. completion date: June 3, 2022

Study information

• Verified date: April 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: June 3, 2022
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

Inclusion Criteria:

• be over 65 years old

• taking antidepressants

• to have presented delirium

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Aged
• Antidepressive Agents
• Delirium

Intervention

Drug:
• Antidepressant
"Delirium" event reported in the World Health Organization global database in subjects aged over 65 years taking antidepressants, comparative analysis by antidepressant class

Locations

Country	Name	City	State
France	Caen University Hospital, Department of Pharmacology	Caen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive analysis of the studied population	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...)	03/01/2022
Primary	Analysis of the association between antidepressant classes and delirium reporting, 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)	03/01/2022
Secondary	Analysis by age group	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)	03/01/2022
Secondary	Analysis of the co-reporting of delirium and hyponatraemia	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).	03/01/2022
Secondary	Analysis of the most prescribed antidepressant	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).	03/01/2022