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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03116100
Other study ID # RNI2016-44 Dr Deschasse
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2017
Est. completion date October 15, 2017

Study information

Verified date May 2020
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Behavioral disorders of psychiatric or neurological origin in the elderly are an emerging public health problem. Its management can include a prescription of psychotropic drugs (anxiolytics, hypnotics, neuroleptics, antidepressants for the most part). Many studies highlight the misuse of psychotropic drugs in this specific and vulnerable population, as well as the need for targeted actions.

As for neuroleptics, there is a deleterious over-prescription in the so-called productive behavioral disorders (cries, agitation, aggressiveness, ambulation), in particular in the patient with Alzheimer's disease (80% of patients) or related. The same applies to behavioral disorders in an acute episode of confusion, which also constitute a situation for the prescribing of psychotropic drugs in the elderly. The frailty of the elderly associated with neuroleptics is the cause of a significant iatrogenic (falls, confusions, excessive sedation, etc.), iatrogeny is largely avoidable.

There is little data on the representation of behavioral disorders in the elderly, whereas the recognition and management of behavioral disorders are functions of the tolerance of the entourage and the training of the caregivers. Significant data exist in the literature about diagnosis, risk factors, factors favoring or triggering behavioral disorders and somatic pathologies to be sought urgently.

The available recommendations on the drug treatment of behavioral disorders are complex and inappropriate in light of new data, including the dangerousness of psychotropic drugs. The deleterious effect of long-term drug treatments is proved. There is no validated drug strategy, especially in acute confusions of the elderly.

One study showed that there was a change in the type of neuroleptic prescribed between 2003 and 2010. Half of the general practitioners studied during this period switched from a first-generation neuroleptic to a second-generation neuroleptic. Nevertheless, the type of molecule chosen remains at the discretion of the treating physician or even required a psychiatric opinion or a passage in the emergencies. In the case where the practitioner initiates a prescription in office, in the home or in EHPAD, certain situations require the choice of a neuroleptic with or without pre-therapeutic assessment.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 15, 2017
Est. primary completion date October 15, 2017
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria:

- General practitioner of the Somme,

- Having patients aged 75 and over

Exclusion Criteria:

- General practitioner with a complementary specialty related to psychiatry, neurology or geriatrics (capacity, university degree or inter-university)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analyzes of the questionnaires on professional practices in patients aged 75 years Analyzes of the questionnaires on professional practices in patients aged 75 years 1 day
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