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

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.

Study Overview

• Status: Completed
• Conditions: Fall; Antidepressants Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Drug: Antidepressive Agents

• Study Type: Observational
• Enrollment (Actual): 100000

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: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 65 years and over who presented fall on antidepressants

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive analysis of the studied population	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.	01/07/2022
Analysis of the association between antidepressant classes and falls reporting, among subjects aged 65 or older	A disproportionality analysis is carried out in multivariate analysis, taking into account some confounding factors (potentially associated illnesses and prescriptions known to induce falls)	01/07/2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis by age group	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)	01/07/2022
Analysis of the most frequent antidepressants	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)	01/07/2022
Mediation analysis	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)	01/07/2022

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: Pharmaco20221004

Drug and device information, study documents

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