Behavior DisordersNEUGERPRATNCT03116100
Clinical Situations Leading to the Prescription of Neuroleptics by General Practitioner in the Elderly. Practice Survey
An observational study of Behavior Disorders and Neuroleptic, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Behavior Disorders, Neuroleptic
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2017to 15 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- General practitioner of the Somme,
- Having patients aged 75 and over
Who cannot join
- General practitioner with a complementary specialty related to psychiatry, neurology or geriatrics (capacity, university degree or inter-university)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Behavior Disorders, Neuroleptic
- Medical subject headings
- Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyzes of the questionnaires on professional practices in patients aged 75 years
Analyzes of the questionnaires on professional practices in patients aged 75 years
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start15 Jun 2017
- Primary completion15 Oct 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116100
- Sponsor's protocol ID
- RNI2016-44 Dr Deschasse
- Acronym
- NEUGERPRAT
- Status last verified
- May 2020
- First submitted
- 11 Apr 2017
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Situations Leading to the Prescription of Neuroleptics by General Practitioner in the Elderly. Practice Survey
- ClinicalTrials.gov ID
- NCT03116100
- Acronym / sponsor ID
- NEUGERPRAT / RNI2016-44 Dr Deschasse
- Conditions
- Behavior Disorders, Neuroleptic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (2 listed)
- General practitioner of the Somme,
- Having patients aged 75 and over
Key exclusion criteria (1 listed)
- General practitioner with a complementary specialty related to psychiatry, neurology or geriatrics (capacity, university degree or inter-university)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analyzes of the questionnaires on professional practices in patients aged 75 years
Time frame: 1 day
Analyzes of the questionnaires on professional practices in patients aged 75 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavior Disorders and Neuroleptic, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyzes of the questionnaires on professional practices in patients aged 75 years (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.