NCT05628467

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100,000 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 65 Years – 120 Years
• Healthy volunteers: —

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

Type	Name	Description
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

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2022-11-28
• Last updated: 2022-11-28

Locations

1 site across 1 country: France