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

Completed

Conditions: schizophrenia
10039628

Registration Number: NL-OMON40128

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

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

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Developing a model for the calculation of the clozapine area under the plasma<br /><br>concentration-time curve from 0 to 12 hours (AUC0-24). </p><br>

Secondary Outcome Measures

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