Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-02 @ 8:14 AM
Study NCT ID:
NCT05628467
Status:
COMPLETED
Last Update Posted:
2022-11-28
First Post:
2022-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Antidepressant Use and Falls in Older Adults: Analysis of the World Health Organization Global Database
Sponsor:
University Hospital, Caen
Organization:
Study Overview
Official Title:
Association Between Antidepressant Use and Falls in Older Adults: Analysis of the World Health Organization Global Database
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: