The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring.

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring should be drawn 12 hours post dose.

The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anders Fink-Jensen, MD, DMSci
• Collaborators: Rigshospitalet, Denmark; University of Copenhagen
• Treatments: Clozapine

Criteria

Inclusion Criteria:

• Age 18 < 65

• Diagnosed with schizophrenia according to the criteria of ICD10 (International Classification of Diseases, World Health Organization) or the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the American Psychiatric Association)

• Unchanged dose of clozapine for the last 30 days

• Usual time of clozapine evening-dose administration between 9 and 12 pm.

Exclusion Criteria:

• Significant drug or alcohol abuse that affects participation in this trial

• Non- or partial compliance of clozapine the day before the trial (assessed by interview)

• Unresponsive by telephone the evening before the trial

• Consumption of clozapine in the morning on the day of the trial

• Significant change in smoking habits within the last 30 days (assessed by interview)

• Significant change of caffeine intake within the last 7 days (assessed by interview)

• Modified use of other antipsychotics within the last 30 days

• Within the last 30 days (7 days for hormone based contraceptives) changes in the use of other medications that can affect s- clozapine during the trial : ( fluvoxamine, ciprofloxacin, hormone based contraceptives, carbamazepine , phenytoin , rifampicin, omeprazole )

• Females who are pregnant or breast-feeding