Association Between Antidepressant Use and Falls in Older Adults: Analysis of the World Health Organization Global Database

Completed

• Conditions: Antidepressants Causing Adverse Effects in Therapeutic Use; Fall

• Registration Number: NCT05628467
• Lead Sponsor: University Hospital, Caen

Brief Summary

The incidence of fall in older adults aged 65 and over is estimated at 30%, and 50% of the people aged 80 and over with at least one fall a year. Falls are associated with significant morbidity and mortality.

The origin falls is often multifactorial, involving intrinsic and extrinsic factors. Few studies have investigated the association with all antidepressants. Potential adverse effects of antidepressants such as hyponatremia, sedation, orthostatic hypotension, extrapyramidal symptoms are known risk factors for falls. Due to multimorbidity, polypharmacy including interaction risks, and aging-related changes in pharmacokinetic and pharmacodynamic of drugs, antidepressants may further increase this risk in older patients.

Based on the World Health Organization global database, the main objective of this study is to investigate the association between antidepressants classes and the occurrence of falls 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 falls.

A mediation analysis will also be performed. It will aim to examine some of the mediators involved in the association between antidepressants classes and falls.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-11-24
• Last Update Submitted: 2022-11-24
• Study First Posted: 2022-11-28
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

• be over 65 years old
• take antidepressants
• have already presented falls

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Descriptive analysis of the studied population	01/07/2022	The investigators describe the profile of patients who are reported in the WORLD HEALTH ORGANIZATION Vigibase pharmacovigilance database, as having experienced a fall. In particular, the number of patients who use antidepressants (Non-selective monoamine reuptake inhibitors, Selective serotonin reuptake inhibitors, Selective serotonin-norepinephrine reuptake inhibitors, Alpha-2-adrenergic receptor antagonists, Monoamine oxidase inhibitors, other antidepressants), the number of patients who presented associated illnesses known to induce falls, the number of patients who presented associated drug prescriptions known to induce falls.
Analysis of the association between antidepressant classes and falls reporting, among subjects aged 65 or older	01/07/2022	A disproportionality analysis is carried out in multivariate analysis, taking into account some confounding factors (potentially associated illnesses and prescriptions known to induce falls)

Secondary Outcome Measures

Name	Time	Method
Analysis of the most frequent antidepressants	01/07/2022	Investigators study the association between most frequent antidepressants and falls reporting among patients aged 65 or older.; We identified most frequent antidepressants as those with more than 1000 cases reported in VigiBase®.; A disproportionality analysis is carried out in multivariate analysis, taking into account some confounding factors (potentially associated illnesses and prescriptions known to induce falls)
Mediation analysis	01/07/2022	Investigators study the association between antidepressant classes and falls reporting analysing the potential role of hyponatraemia and delirium as mediators. This analysis is carried out taking into account some confounding factors (potentially associated illnesses and prescriptions known to induce falls)
Analysis by age group	01/07/2022	Investigators study the association between antidepressant classes and falls 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 some confounding factors (potentially associated illnesses and prescriptions known to induce falls)

Trial Locations

Locations (1)

Caen University Hospital, Department of Pharmacology; 🇫🇷 Caen, Normandie, France