Use of Antipsychotics in Palliative Care (NEUROPAL) (NEUROPAL)

May 15, 2017 updated by: University Hospital, Caen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in palliative care, regardless of the stage of their progressive, life-threatening disease (as defined by ANAES and SFAP)

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
change of dosage of the associated treatments
Time Frame: comparison between the dosage of each associated treatment at Day 0 and Day 7
comparison between the dosage of each associated treatment at Day 0 and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Caen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Christophe KASSEL, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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