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

Sponsor
University Hospital, Caen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05356078
Collaborator
(none)
10,000
1
5
2015.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Association Between Prescription of Antidepressants and Delirium in the Elderly : Analysis From the World Health Organization Global Database
Actual Study Start Date :
Jan 3, 2022
Actual Primary Completion Date :
Feb 3, 2022
Anticipated Study Completion Date :
Jun 3, 2022

Outcome Measures

Primary Outcome Measures

  1. 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...)

  2. 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

  1. 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)

  2. 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).

  3. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • be over 65 years old

  • taking antidepressants

  • to have presented delirium

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Caen University Hospital, Department of Pharmacology Caen Normandie France 14033

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT05356078
Other Study ID Numbers:
  • Pharmaco20220103
First Posted:
May 2, 2022
Last Update Posted:
May 2, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2022