NCT02625103

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

November 13, 2015

Last Update Submit

February 24, 2016

Conditions

Schizophrenia

Keywords

Schizophrenia, Clozapine, TDM, Serum Concentration

Outcome Measures

Primary Outcomes (1)

  • Percentage change in serum-clozapine

    10 - 14 hours post drug administration

Secondary Outcomes (1)

  • Percentage change in serum-clozapine (multiple shorter ranges)

    < 10 -14 hours post dose

Study Arms (1)

Clozapine

EXPERIMENTAL

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

Procedure: Blood samplingDrug: Clozapine

Interventions

Blood samplingPROCEDURE

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
ClozapineDRUG

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

Also known as: Leponex
Clozapine

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Centre Rigshospitalet

Copenhagen, København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Blood Specimen CollectionClozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Anders Fink-Jensen, MD, DMSci

    Psychiatric Centre Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD, DMSci

Study Record Dates

First Submitted

November 13, 2015

First Posted

December 9, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

February 25, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)