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

NCT05356078 | Unknown

• 1 other identifier: Pharmaco20220103
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Antidepressive Agents; Aged; Delirium

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Interventions

Antidepressant DRUG

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

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital, Department of Pharmacology

Caen, Normandy, 14033, France

Location

MeSH Terms

Conditions

Delirium

Interventions

Antidepressive Agents

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: May 2, 2022
• Study Start: January 3, 2022
• Primary Completion: February 3, 2022
• Study Completion: June 3, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)