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

NCT ID: NCT05628467

Last Updated: 2022-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Antidepressants Causing Adverse Effects in Therapeutic Use Fall

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

65 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caen University Hospital, Department of Pharmacology

Caen, Normandy, France

Site Status

Countries

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France

Other Identifiers

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Pharmaco20221004

Identifier Type: -

Identifier Source: org_study_id

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