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Clozapine Hematological Monitoring Regulatory Compliance Assessment in Psychiatry

Clozapine Hematological Monitoring Regulatory Compliance Assessment in Psychiatry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06610500
Enrollment
20
Registered
2024-09-24
Start date
2023-05-16
Completion date
2023-09-12
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agranulocytosis, Schizophrenia

Keywords

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

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.

Interventions

OTHERQuestionnaires

Questionnaires investigating the prescription and dispensing of clozapine.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of non-complianceMonth: 2Rate of non-compliance in the circuits for prescribing, dispensing clozapine

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026