Clozapine Hematological Monitoring Regulatory Compliance Assessment in Psychiatry

September 20, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
Clozapine is a drug that requires regular and diligent hematological monitoring throughout its use. This follow-up is, in France, framed by a compulsory paper format of the blood count follow-up notebook for each patient. Due to the multiplicity of the different modes of transmission of the different documents necessary for compliance with the regulations for the prescription, dispensing and administration of clozapine, we decided to carry out a current inventory in the department of Loire with respect for the latter. The main objective of this study is to assess the rate of non-compliance in circuits of prescription, dispensing and administration of clozapine by sending a questionnaire on habits of prescriptions, dispensing and administration of health professionals (psychiatrists, pharmacists), and by sending a questionnaire to the patients treated by clozapine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

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

Study Locations

  • France
      • Saint-Étienne, France, 42000
        • CHU Saint Etienne

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients treated and stabilised on clozapine by the St-Etienne Psychiatry Department Private and hospital psychiatrists in the Loire Pharmacists and hospital pharmacists in the Loire

Description

Inclusion Criteria:

  • Population 1: all patients stabilized of Medical-Psychological Center (CMP) of St-Etienne treated with clozapine
  • Population 2 : all psychiatrists of the Loire department
  • Population 2 : all pharmacists of the Loire department

Exclusion Criteria:

NA

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Population 1
Patients treated and stabilised by clozapine in the active queue of Medical-Psychological Center (CMP) of St-Etienne
Other: Questionnaires
Questionnaires investigating the prescription and dispensing of clozapine.
Population 2
Liberal psychiatrists practising in the Loire department, and hospital psychiatrists
Other: Questionnaires
Questionnaires investigating the prescription and dispensing of clozapine.
Population 3
Pharmacists practising in community pharmacies dispensing clozapine to patients, hospital Pharmacists in the Loire
Other: Questionnaires
Questionnaires investigating the prescription and dispensing of clozapine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of non-compliance
Time Frame: Month: 2
Rate of non-compliance in the circuits for prescribing, dispensing clozapine
Month: 2

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Anne-Cécile GALLO BLANDIN, MD, CHU Saint Etienne

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 (Actual)

May 16, 2023

Primary Completion (Actual)

September 12, 2023

Study Completion (Actual)

September 12, 2023

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN682023/CHUSTE

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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