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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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Antidepressants Causing Adverse Effects in Therapeutic Use
  • Fall

NCT number NCT05628467
Study type Observational
Source University Hospital, Caen
Contact
Status Completed
Phase
Start date July 1, 2022
Completion date August 1, 2022

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