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CompletedNCT06610500Updated Sep 24, 2024

Clozapine Hematological Monitoring Regulatory Compliance Assessment in Psychiatry

An observational study in Schizophrenia and Agranulocytosis, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-24.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia
  • Agranulocytosis

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Keywords

  • Clozapine
  • schizophrenia
  • hematological monitoring
  • agranulocytosis
  • regulation
  • paper tracking book
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 20 is below the median of 178 across 491 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

Exclusion Criteria:

NA

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherQuestionnaires

    Questionnaires investigating the prescription and dispensing of clozapine.

06

What researchers measure

Primary outcomes

  1. Rate of non-compliance

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

    Time frame: Month: 2

07

Study locations

1 site
  • CHU Saint Etienne
    Saint-Étienne, 42000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06610500
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Sep 24, 2024
Start date
May 16, 2023
Primary completion
Sep 12, 2023
Completion
Sep 12, 2023
Last update
Sep 24, 2024

Study contacts

Anne-Cécile GALLO BLANDIN, MD
principal investigator · CHU Saint Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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