NCT06749041Not yet recruiting
Nor)Clozapine Kinetics and Side Effects in Therapy Resistant Schizophrenia and the Optimal Sampling Time for Therapeutic Drug Monitoring
Clozapine OpTimal Timing for Optimal moNitoring and Side Effects
Source: ClinicalTrials.gov · Last updated 30 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this observational study is to better understand how clozapine treatment can be tailored as regards minimizing side effects and optimizing efficacy and monitoring. Firstly, how clozapine is broken down into norclozapine in the liver and how both clozapine and norclozapine affect side effects are examined. In order to investigate this metabolization process in the liver inflammation levels in the blood are assessed, which inhibit the conversion of clozapine into norclozapine. In addition, various factors related to physical health are assessed, such as blood sugar, cholesterol, weight, waist circumference, blood pressure and heart rate. The role of hormones is investigated, such as cortisol, a stress hormone that affects metabolism and stress levels. Amino acids are examined, which are building blocks of proteins, and specific parts of DNA that influence clozapine metabolism. In addition, investigation follows whether 12 hours after ingestion is a well-chosen time at which the amount of clozapine is measured in the blood in case of ingestion once a day and twice a day. Finally, specific side effects of clozapine are assessed - with special attention to stool - and the severity of the psychiatric symptoms in patients with therapy resistant schizophrenia spectrum disorders.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 19 Dec 2024
- Start date
- 23 Dec 2024
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- GGZ Noord-Holland-Noord
- Diseases
- Schizophrenia
- NCT number
- NCT06749041
What you commit to
- Study type: Observational
- Planned participants: 60
- From 23 Dec 2024 to the primary completion date, 1 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Malignancy or treatment with immunosuppressive medication.
- Samples where cessation, start or dose change of interacting co-medication (such as valproic acid, gemfibrozil, fluvoxamine, omeprazole and cyclic oral contraceptives \[21 on, 7 days off\]) or changes in use of tobacco containing products occurred within seven days prior to blood sampling (21, 28, 34, 35).
- Acute inflammation, infection or samples shortly after intoxication. In case this information is unknown, it may be derived by large unexpected change in levels compared to previous or target levels.
Other
- Pregnancy.
- Not sampled at Starlet (blood collection site) or sampled by dried blood spot
- Unknown status of smoking (including vaping).
- Unknown time of intake of clozapine.
- Unknown time of blood sampling.
- If informed consent is not obtained by the patient or by a legal representative in a mentally incapacitated patient, i.e. a legally incompetent adult.
Who the study is looking for
- Standard treatment of a stable, oral dose of clozapine for at least one week (at steady state).
- Age between 18-70 years.
- Registered time of intake as well as sampling time and dosage.
- Registered smoking status (yes/no).
- At least two samples in the elimination phase of clozapine with both clozapine and norclozapine measured.
- Measurement of the white cell count at least every three months or more often.
- Routine metabolic screening performed at moment of inclusion.
- Subjects should be able to understand the study information and procedures and give informed consent or when incapacitated subjects are not reliably able to give informed consent their legal representatives should give informed consent under the condition that these subjects are willing to participate.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.