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Completed

NCT Number: NCT05628467

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.

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Key information

Conditions

Antidepressants Causing Adverse Effects in Therapeutic Use Fall

Age range

65 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital, Department of Pharmacology

Caen, Normandy, 14033, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

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

Primary outcomes

  1. Descriptive analysis of the studied population

    Time frame: 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.

  2. Analysis of the association between antidepressant classes and falls reporting, among subjects aged 65 or older

    Time frame: 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 outcomes

  1. Analysis by age group

    Time frame: 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)

  2. Analysis of the most frequent antidepressants

    Time frame: 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)

  3. Mediation analysis

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 28, 2022
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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