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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05356078
Enrollment
10000
Registered
2022-05-02
Start date
2022-01-03
Completion date
2022-06-03
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antidepressive Agents, Aged, Delirium

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.

Interventions

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

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Descriptive analysis of the studied population03/01/2022From 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 older03/01/2022A disproportionality analysis is carried out in multivariate analysis, taking into account a certain number of confounding factors (co-prescriptions and comorbidities)

Secondary

MeasureTime frameDescription
Analysis of the co-reporting of delirium and hyponatraemia03/01/2022Investigators 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 by age group03/01/2022Investigators 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 most prescribed antidepressant03/01/2022Investigators 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026