NCT03116100

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2017

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

April 11, 2017

Last Update Submit

May 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Describe the prescription of neuroleptics in patients aged 75 years or older in 2016 in chronic hallucinatory psychosis, behavioral disorders in dementia and confusional outpatient syndrome in general practitioners in the Somme

You may qualify if:

  • General practitioner of the Somme,
  • Having patients aged 75 and over

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 14, 2017

Study Start

June 15, 2017

Primary Completion

October 15, 2017

Study Completion

October 15, 2017

Last Updated

June 2, 2020

Record last verified: 2020-05

Locations