SchizophreniaNCT06610500
Clozapine Hematological Monitoring Regulatory Compliance Assessment in Psychiatry
An observational study of Schizophrenia and Agranulocytosis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Agranulocytosis
- What is being tested?
- Questionnaires
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2023to 12 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Questionnaires
- Keywords
- Clozapine, schizophrenia, hematological monitoring, agranulocytosis, regulation, paper tracking book
- Medical subject headings
- Schizophrenia, Agranulocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Questionnaires investigating the prescription and dispensing of clozapine.
| Study group | Role | What they receive |
|---|---|---|
| Population 1 | Patients treated and stabilised by clozapine in the active queue of Medical-Psychological Center (CMP) of St-Etienne Receives: Other: Questionnaires | |
| Population 2 | Liberal psychiatrists practising in the Loire department, and hospital psychiatrists Receives: Other: Questionnaires | |
| Population 3 | Pharmacists practising in community pharmacies dispensing clozapine to patients, hospital Pharmacists in the Loire Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of non-compliance
Rate of non-compliance in the circuits for prescribing, dispensing clozapine
Measured: Month: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start16 May 2023
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Cécile GALLO BLANDIN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610500
- Sponsor's protocol ID
- IRBN682023/CHUSTE
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clozapine Hematological Monitoring Regulatory Compliance Assessment in Psychiatry
- ClinicalTrials.gov ID
- NCT06610500
- Acronym / sponsor ID
- IRBN682023/CHUSTE
- Conditions
- Schizophrenia, Agranulocytosis
- Keywords
- Clozapine, schizophrenia, hematological monitoring, agranulocytosis, regulation, paper tracking book
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Population 1 | – | Other: QuestionnairesPatients treated and stabilised by clozapine in the active queue of Medical-Psychological Center (CMP) of St-Etienne |
| Population 2 | – | Other: QuestionnairesLiberal psychiatrists practising in the Loire department, and hospital psychiatrists |
| Population 3 | – | Other: QuestionnairesPharmacists practising in community pharmacies dispensing clozapine to patients, hospital Pharmacists in the Loire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires investigating the prescription and dispensing of clozapine. | Other | Population 1, Population 2, Population 3 |
Primary outcome
Rate of non-compliance
Time frame: Month: 2
Rate of non-compliance in the circuits for prescribing, dispensing clozapine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Cécile GALLO BLANDIN, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Agranulocytosis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of non-compliance (time frame: Month: 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.