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

NCT ID: NCT02625103

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-02-29

Brief 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 .

Detailed Description

Several factors can influence s-clozapine and thereby the occurence of dose-related adverse reactions and level of treatment response. The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring are recommended to be drawn 12 hours post dose. Uncertainty regarding the timing of blood sampling and the individual pharmakokinetics for clozapine +/- 2 hours from the 12-hour timepoint, leads to uncertainty regarding the comparability of serum concentrations and the information hold within them.

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 .

In addition we want to investigate if any of the following covariates might affect the change of s-clozapine and s-N-desmethyl-clozapine: Sex, age, BMI, co-medications, signs of infection, caffeine intake and smoking.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Clozapine

treatment as usual: administration of clozapine between 9 and 12 pm. Blood sampling 10 -14 hours post drug administration

Group Type: EXPERIMENTAL

Blood sampling

Intervention Type: PROCEDURE

blood samples for s-clozapine and s-desmethyl-clozapine analysis are collected at 10, 11, 12, 13 and 14 hours post evening-clozapine-administration

Clozapine

Intervention Type: DRUG

Registration of the exact time of drug administration. Also postponement of any morning clozapine administration until ended blood sampling.

Interventions

Blood sampling

blood samples for s-clozapine and s-desmethyl-clozapine analysis are collected at 10, 11, 12, 13 and 14 hours post evening-clozapine-administration

Intervention Type: PROCEDURE

Clozapine

Registration of the exact time of drug administration. Also postponement of any morning clozapine administration until ended blood sampling.

Intervention Type: DRUG

Other Intervention Names

Leponex

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Anders Fink-Jensen, MD, DMSci

OTHER

Sponsor Role: lead

Responsible Party

Anders Fink-Jensen, MD, DMSci

Professor, MD, DMSci

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anders Fink-Jensen, MD, DMSci

Role: PRINCIPAL_INVESTIGATOR

Psychiatric Centre Rigshospitalet

Locations

Psychiatric Centre Rigshospitalet

Copenhagen, København Ø, Denmark

Countries

Denmark

Other Identifiers

2015-002520-82

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLO-MEAS

Identifier Type: -

Identifier Source: org_study_id