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

NCT05628467 | Completed

• 1 other identifier: Pharmaco20221004
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Antidepressants Causing Adverse Effects in Therapeutic Use; Fall

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Analysis by age group

  01/07/2022

• Analysis of the most frequent antidepressants

  01/07/2022

• Mediation analysis

  01/07/2022

Interventions

Antidepressive Agents DRUG

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

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 65 years and over who presented fall on antidepressants

You may qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital, Department of Pharmacology

Caen, Normandy, 14033, France

Location

MeSH Terms

Interventions

Antidepressive Agents

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 28, 2022
• Study Start: July 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-10

Locations

FR (1)