Development of an optimal sampling strategy for clozapine to predict area under the concentration-time curve ratios and the clinical validation of the dried blood spot analysis for clozapine

Development of an optimal sampling strategy for clozapine to predict area under the concentration-time curve ratios and the clinical validation of the dried blood spot analysis for clozapine - Optimal sampling model and clinical validation of DBS for clozapine

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40128

Enrollment

Registered

2014-05-13

Start date

2014-06-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

schizophrenia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Stable treatment with clozapine for at least two weeks Caucasian ethnicity Age between 18 and 55 years

Exclusion criteria

Exclusion criteria: Patients who start a treatment with any of the drugs descriped below less than three days before blood sampling are excluded from participation in this study (in case of amidaron within 6 months). Patients who already use these drugsfor longer than three days are not excluded from the study, unless there is a change in usage or dosage less than three days before sampling. Amiodarone Cimetidine Fluoroquinolones Fluvoxamine Furafylline Interferon Methoxsalen Mibefradil Insulin Methylcholanthrene Modafinil Nafcillin Beta-Naphthoflavone Omeprazole

Design outcomes

Primary

Measure	Time frame
Developing a model for the calculation of the clozapine area under the plasma concentration-time curve from 0 to 12 hours (AUC0-24).	—

Secondary

Measure	Time frame
- Comparing the clozapine drug levels obtained by venous blood sampling with the clozapine drug levels obtained by finger prick DBS sampling and venous DBS sampling. - to determine which sample points or combination of sample point(s) using the developed model gives the best estimate of the AUC of clozapine (optimal sampling). - To perform an external validation of the model using concentration-time data of clozapine from Russian patients.	—

Measure

Time frame

- Comparing the clozapine drug levels obtained by venous blood sampling with the clozapine drug levels obtained by finger prick DBS sampling and venous DBS sampling. - to determine which sample points or combination of sample point(s) using the developed model gives the best estimate of the AUC of clozapine (optimal sampling). - To perform an external validation of the model using concentration-time data of clozapine from Russian patients.

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Countries

Netherlands

Outcome results