Actively Recruiting

Phase Not Applicable
Age: 75Years +
All Genders
NCT05991037

Relation Between Psychoactive Drugs Overdosage and Severity of Falls in Elderly People

Led by University Hospital, Caen · Updated on 2025-07-25

400

Participants Needed

1

Research Sites

209 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

There are many epidemiological data on the relationship between the number or nature of psychoactive medications used and the risk of falling in elderly, but very little on the relationship between the amount of psychoactive medication actually present in the blood and the severity of the fall. However, the inevitable drug-drug interactions related to polypharmacy and the pharmacokinetic modifications related to old age may lead plasma overdose situations which can potentiate the risk of falls but also aggravate these consequences. The investigators therefore propose a study with the objective of verifying whether the proportion of falls with serious traumatic consequences is more frequent in patients over 75 years old, presenting plasma overdoses of psychoactive drugs (plasma concentrations higher than the usual therapeutic concentrations) in regard to those between therapeutic ranges. The aim of this work is to verify if the falls present more severe characters when the psychoactive drug concentrations are beyond the usual therapeutic ranges.

CONDITIONS

Official Title

Relation Between Psychoactive Drugs Overdosage and Severity of Falls in Elderly People

Who Can Participate

Age: 75Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 75 years or older admitted to the emergency room for a fall and planned for hospitalization
  • Patients taking at least one psychoactive drug listed in the study protocol
  • Patients able to move before hospitalization, with or without technical assistance
  • Patients who have signed informed consent
  • Patients covered by the social security system
Not Eligible

You will not qualify if you...

  • Patients not requiring hospitalization after the emergency room visit
  • Patients who fell more than 12 hours before study inclusion (blood sampling)
  • Patients with Parkinson's disease or who fell following a convulsive seizure
  • Patients with a very short-term life-threatening prognosis (e.g., in shock or palliative care planned from emergency room)
  • Patients who are wheelchair-bound or bedridden
  • Adults under legal protection such as guardianship or curatorship
  • Patients who do not understand the French language

AI-Screening

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Trial Site Locations

Total: 1 location

1

Caen University Hospital

Caen, France

Actively Recruiting

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Research Team

V

Véronique Lelong-Boulouard, PhD

CONTACT

C

Cédric Villain, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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