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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Blood sampling
Clozapine
Sponsored by
Anders Fink-Jensen, MD, DMSci
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia focused on measuring Schizophrenia, Clozapine, TDM, Serum Concentration

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatric Centre Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clozapine

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage change in serum-clozapine

Secondary Outcome Measures

Percentage change in serum-clozapine (multiple shorter ranges)

Full Information

First Posted
November 13, 2015
Last Updated
February 24, 2016
Sponsor
Anders Fink-Jensen, MD, DMSci
Collaborators
University of Copenhagen, Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02625103
Brief Title
The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring.
Official Title
The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anders Fink-Jensen, MD, DMSci
Collaborators
University of Copenhagen, Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Clozapine, TDM, Serum Concentration

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clozapine
Arm Type
Experimental
Arm Description
treatment as usual: administration of clozapine between 9 and 12 pm. Blood sampling 10 -14 hours post drug administration
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
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
Drug
Intervention Name(s)
Clozapine
Other Intervention Name(s)
Leponex
Intervention Description
Registration of the exact time of drug administration. Also postponement of any morning clozapine administration until ended blood sampling.
Primary Outcome Measure Information:
Title
Percentage change in serum-clozapine
Time Frame
10 - 14 hours post drug administration
Secondary Outcome Measure Information:
Title
Percentage change in serum-clozapine (multiple shorter ranges)
Time Frame
< 10 -14 hours post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Fink-Jensen, MD, DMSci
Organizational Affiliation
Psychiatric Centre Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Centre Rigshospitalet
City
Copenhagen
State/Province
København Ø
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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