Antipsychotics in Palliative CareNEUROPALNCT03155685
Use of Antipsychotics in Palliative Care (NEUROPAL)
An observational study of Antipsychotics in Palliative Care, run by University Hospital, Caen.
Trial summary
There are not lots of recommendations for the use of antipsychotics in palliative care. The National Agency for Accreditation and Evaluation in Health (ANAES) and the French Society for Accompaniment and Palliative Care, in 2002, make it the first-line treatment for confusion in palliative care, but there are no… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antipsychotics in Palliative Care
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2017to May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in palliative care, regardless of the stage of their progressive, life-threatening disease (as defined by ANAES and SFAP)
Who may be able to join
- all patients over the age of 18 years in palliative care, regardless of the stage of their illness, and according to the definition used by ANAES and SFAP (all patients suffering from a serious, progressive disease involving life-threatening, advanced or terminal).
- having a social security cover
- not taking antipsychotics at the time of inclusion, nor within 3 days before inclusion.
- for whom the doctor, investigator, decides to prescribe an antipsychotic, whatever it is, whatever the symptom motivating this prescription, whatever the dosage and the route of administration used.
- Drugs related to antipsychotics, such as metoclopramide, metopimazine, alizapride or domperidone, are not included in this study.
Who cannot join
- patients with contraindications to antipsychotics
- patients already taking an antipsychotic, or for whom an antipsychotic was stopped less than 3 days ago.
- patients under 18 years of age.
- pregnant women
- patients protected by the law
- patients who are unable to refrain from participating in a study, and for whom the entourage (a trusted person, relatives, etc.) is also unable to refrain from such participation.
- The study can be released at any time at the request of the patient and / or his entourage.
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Trial locations and contacts
No sites are listed yet.
About this study
Official title: Of the Use of Antipsychotics in Palliative Care : Prospective, Multicenter, Observational Study.
There are not lots of recommendations for the use of antipsychotics in palliative care. The National Agency for Accreditation and Evaluation in Health (ANAES) and the French Society for Accompaniment and Palliative Care, in 2002, make it the first-line treatment for confusion in palliative care, but there are no information on the molecules to be used, the dosage or the route of administration.
Many symptoms can motivate the prescription of an antipsychotic and many molecules exist. Their mode of action is substantially the same but their pharmacological properties sometimes give them different beneficial effects or side effects. They are studied in psychiatry but very little in palliative care.
Read more
Depending on the symptom (s) presented by the patient, either of these antipsychotics may be preferred. Use appear to differ from one center to another.
The investigator propose a multicenter, prospective, observational study describing the antipsychotics used according to the symptom.
This study should include 100 patients over the age of 18 years in palliative care (regardless of pathology) who are not taking antipsychotics and for whom the decision to introduce an antipsychotic is made regardless of the symptom.
The purpose of this work is to describe the most commonly used antipsychotic according to a particular symptom, as well as the dosage and route of administration.
The investigator will also evaluate the 7-day efficacy of the chosen antipsychotic on the symptom that motivated the prescription, and we will compare the dosages of the associated treatments before and after the introduction of this new treatment.
Read the detailed description
The investigator will question the practice of palliative care physicians in several centers regarding the use of antipsychotics.
When a patient meeting the inclusion criteria has been identified by an investigating physician. The participant fills out a questionnaire containing some general information about the investigating physician and the patient, followed by a first questionnaire, called A Form (to be completed on D0, when the antipsychotic is introduced) with 8 questions on the prescribing symptom, antipsychotic used and associated therapies.
Seven days later, the same physician will fill out a second form, called B Form (to be completed on D7), with 9 questions on treatment efficacy, possible modifications and associated treatments.
Each investigating physician includes a maximum of 4 patients over the 6-month inclusion period.
Once the 4 questionnaires have been completed (Form A and Form B), he / she returns it to the principal investigator of the study, by e-mail to etudeneuropal@gmail.com, or by mail: Dr Marie LEPOUPET, Mobile Pain-Palliative Care Unit CHU, Côte de Nacre Avenue, 14,000 CAEN.
- Conditions
- Antipsychotics in Palliative Care
- Keywords
- antipsychotic, palliative care
What is being measured
The primary outcome is the main question the study is designed to answer.
antipsychotic name (ICD)
name (ICD) of the antipsychotic used according to the symptom presented by the patient
Measured: when the antipsychotic is first prescribed by the investigator and so the patient included in the study, up to 6 months between the beginning of the study and the patient inclusion
administration route
Per os, Subcutaneous, Intravenous, Sublingual, Intramuscular
Measured: when the antipsychotic is first prescribed by the investigator and so the patient included in the study, up to 6 months between the beginning of the study and the patient inclusion
daily dosage
milligrams per day
Measured: when the antipsychotic is first prescribed by the investigator and so the patient included in the study, up to 6 months between the beginning of the study and the patient inclusion
Secondary outcomes (2)
simple verbal scale of efficiency of the antipsychotic on the symptom
simple verbal scale : weak, medium, strong, very strong
Measured: evaluation by the patient or the investigator if patient impossible, 7 days after the introduction of the antipsychotic.
change of dosage of the associated treatments
Measured: comparison between the dosage of each associated treatment at Day 0 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startMay 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antipsychotics in Palliative CareStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe KASSEL, Study director, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155685
- Sponsor's protocol ID
- 16-151
- Acronym
- NEUROPAL
- Status last verified
- May 2017
- First submitted
- 5 May 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Of the Use of Antipsychotics in Palliative Care : Prospective, Multicenter, Observational Study.
- ClinicalTrials.gov ID
- NCT03155685
- Acronym / sponsor ID
- NEUROPAL / 16-151
- Conditions
- Antipsychotics in Palliative Care
- Keywords
- antipsychotic, palliative care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 16 May 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.
There are not lots of recommendations for the use of antipsychotics in palliative care. The National Agency for Accreditation and Evaluation in Health (ANAES) and the French Society for Accompaniment and Palliative Care, in 2002, make it the first-line treatment for confusion in palliative care, but there are no information on the molecules to be used, the dosage or the route of administration.
Many symptoms can motivate the prescription of an antipsychotic and many molecules exist. Their mode of action is substantially the same but their pharmacological properties sometimes give them different beneficial effects or side effects. They are studied in psychiatry but very little in palliative care.
Depending on the symptom (s) presented by the patient, either of these antipsychotics may be preferred. Use appear to differ from one center to another.
The investigator propose a multicenter, prospective, observational study describing the antipsychotics used according to the symptom.
This study should include 100 patients over the age of 18 years in palliative care (regardless of pathology) who are not taking antipsychotics and for whom the decision to introduce an antipsychotic is made regardless of the symptom.
The purpose of this work is to describe the most commonly used antipsychotic according to a particular symptom, as well as the dosage and route of administration.
The investigator will also evaluate the 7-day efficacy of the chosen antipsychotic on the symptom that motivated the prescription, and we will compare the dosages of the associated treatments before and after the introduction of this new treatment.
Detailed description
The investigator will question the practice of palliative care physicians in several centers regarding the use of antipsychotics.
When a patient meeting the inclusion criteria has been identified by an investigating physician. The participant fills out a questionnaire containing some general information about the investigating physician and the patient, followed by a first questionnaire, called A Form (to be completed on D0, when the antipsychotic is introduced) with 8 questions on the prescribing symptom, antipsychotic used and associated therapies.
Seven days later, the same physician will fill out a second form, called B Form (to be completed on D7), with 9 questions on treatment efficacy, possible modifications and associated treatments.
Each investigating physician includes a maximum of 4 patients over the 6-month inclusion period.
Once the 4 questionnaires have been completed (Form A and Form B), he / she returns it to the principal investigator of the study, by e-mail to etudeneuropal@gmail.com, or by mail: Dr Marie LEPOUPET, Mobile Pain-Palliative Care Unit CHU, Côte de Nacre Avenue, 14,000 CAEN.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in palliative care, regardless of the stage of their progressive, life-threatening disease (as defined by ANAES and SFAP)
Key inclusion criteria (5 listed)
- all patients over the age of 18 years in palliative care, regardless of the stage of their illness, and according to the definition used by ANAES and SFAP (all patients suffering from a serious, progressive disease involving life-threatening, advanced or terminal).
- having a social security cover
- not taking antipsychotics at the time of inclusion, nor within 3 days before inclusion.
- for whom the doctor, investigator, decides to prescribe an antipsychotic, whatever it is, whatever the symptom motivating this prescription, whatever the dosage and the route of administration used.
- Drugs related to antipsychotics, such as metoclopramide, metopimazine, alizapride or domperidone, are not included in this study.
Key exclusion criteria (8 listed)
- patients with contraindications to antipsychotics
- patients already taking an antipsychotic, or for whom an antipsychotic was stopped less than 3 days ago.
- patients under 18 years of age.
- pregnant women
- patients protected by the law
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
antipsychotic name (ICD)
Time frame: when the antipsychotic is first prescribed by the investigator and so the patient included in the study, up to 6 months between the beginning of the study and the patient inclusion
name (ICD) of the antipsychotic used according to the symptom presented by the patient
administration route
Time frame: when the antipsychotic is first prescribed by the investigator and so the patient included in the study, up to 6 months between the beginning of the study and the patient inclusion
Per os, Subcutaneous, Intravenous, Sublingual, Intramuscular
daily dosage
Time frame: when the antipsychotic is first prescribed by the investigator and so the patient included in the study, up to 6 months between the beginning of the study and the patient inclusion
milligrams per day
2 secondary outcomes
simple verbal scale of efficiency of the antipsychotic on the symptom
Time frame: evaluation by the patient or the investigator if patient impossible, 7 days after the introduction of the antipsychotic.
change of dosage of the associated treatments
Time frame: comparison between the dosage of each associated treatment at Day 0 and Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Individual participant dataSharing planned: No
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.
Christophe KASSEL study director
University Hospital, Caen
Questions about this trial
What is this clinical trial studying?
An observational study of Antipsychotics in Palliative Care, run by University Hospital, Caen.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LEPOUPET (02.31.06.51.49 ext. +33, etudeneuropal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antipsychotic name (ICD) (time frame: when the antipsychotic is first prescribed by the investigator and so the patient included in the study, up to 6 months between the beginning of the study and the patient inclusion). The study lists 3 primary outcomes in all. 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 16 May 2017.