Clozapine Hematological Monitoring Regulatory Compliance Assessment in Psychiatry

Completed

• Conditions: Schizophrenia; Agranulocytosis
• Interventions: Other: Questionnaires

• Registration Number: NCT06610500
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-16
• Primary Completion: 2023-09-12
• Study Completion: 2023-09-12
• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of non-compliance	Month: 2	Rate of non-compliance in the circuits for prescribing, dispensing clozapine

Trial Locations

Locations (1)

CHU Saint Etienne; 🇫🇷 Saint-Étienne, France