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

NCT02625103 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-02-25

No results posted yet for this study

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 .

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Anders Fink-Jensen, MD, DMSci

    lead OTHER

Principal Investigators

  • Anders Fink-Jensen, MD, DMSci · Psychiatric Centre Rigshospitalet

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-12-31
Completion
2016-02-29

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02625103 on ClinicalTrials.gov