Clozapine Hematological Monitoring Regulatory Compliance Assessment in Psychiatry

NCT06610500 | Completed

• 1 other identifier: IRBN682023/CHUSTE
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Agranulocytosis

Keywords

Clozapine; schizophrenia; hematological monitoring; agranulocytosis; regulation; paper tracking book

Outcome Measures

Primary Outcomes (1)

• Rate of non-compliance

  Rate of non-compliance in the circuits for prescribing, dispensing clozapine

  Month: 2

Study Arms (3)

Population 1

Patients treated and stabilised by clozapine in the active queue of Medical-Psychological Center (CMP) of St-Etienne

Other: Questionnaires

Population 2

Liberal psychiatrists practising in the Loire department, and hospital psychiatrists

Other: Questionnaires

Population 3

Pharmacists practising in community pharmacies dispensing clozapine to patients, hospital Pharmacists in the Loire

Other: Questionnaires

Interventions

Questionnaires OTHER

Questionnaires investigating the prescription and dispensing of clozapine.

Population 1; Population 2; Population 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Schizophrenia; Agranulocytosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anne-Cécile GALLO BLANDIN, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: May 16, 2023
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)