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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625103
• Other study ID #: CLO-MEAS
• Secondary ID: 2015-002520-82
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2015
• Last updated: February 24, 2016
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Psychiatric Centre Rigshospitalet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Procedure:
• 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

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

Locations

Country	Name	City	State
Denmark	Psychiatric Centre Rigshospitalet	Copenhagen	København Ø

Sponsors (3)

Lead Sponsor	Collaborator
Anders Fink-Jensen, MD, DMSci	Rigshospitalet, Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in serum-clozapine		10 - 14 hours post drug administration	No
Secondary	Percentage change in serum-clozapine (multiple shorter ranges)		< 10 -14 hours post dose	No