Antipsychotics in Palliative Care Clinical Trial
— NEUROPALOfficial 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.
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.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | May 2018 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Caen |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | antipsychotic name (ICD) | name (ICD) of the antipsychotic used according to the symptom presented by the patient | 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 | |
| Primary | administration route | Per os, Subcutaneous, Intravenous, Sublingual, Intramuscular | 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 | |
| Primary | daily dosage | milligrams per day | 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 | simple verbal scale of efficiency of the antipsychotic on the symptom | simple verbal scale : weak, medium, strong, very strong | evaluation by the patient or the investigator if patient impossible, 7 days after the introduction of the antipsychotic. | |
| Secondary | change of dosage of the associated treatments | comparison between the dosage of each associated treatment at Day 0 and Day 7 |