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

NCT05628467 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100000

Last updated 2022-11-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Eligibility

Min Age
65 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2022-08-01
Completion
2022-08-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05628467 on ClinicalTrials.gov