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

Fall Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05628467
• Other study ID #: Pharmaco20221004
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: October 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100000
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

Inclusion Criteria:

• be over 65 years old

• take antidepressants

• have already presented falls

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Antidepressants Causing Adverse Effects in Therapeutic Use
• Fall

Intervention

Drug:
• Antidepressive Agents
Compare the signal obtained from the pharmacovigilance database study between adults over 65 who fall on antidepressants versus those who fall on other drugs

Locations

Country	Name	City	State
France	Caen University Hospital, Department of Pharmacology	Caen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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