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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Delirium; Aged; Antidepressive Agents
• Intervention / Treatment: Drug: Antidepressant

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• France
  • Normandie
    • Caen, Normandie, France, 14033
      • Caen University Hospital, Department of Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 120 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 65 years and over who presented with delirium on antidepressants

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2022
• Primary Completion (ACTUAL): February 3, 2022
• Study Completion (ANTICIPATED): June 3, 2022

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (ACTUAL): May 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: Pharmaco20220103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No