Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ) (CHEMPAQ)

November 4, 2011 updated by: University of Aarhus
Clozapine remain the drug of choice for treatment resistant schizophrenia and up to 60% of patients not responding to other antipsychotics will respond to clozapine. However, the use of clozapine is restricted due to the risk of agranulocytosis and consequently the need for mandatory hematological monitoring. CHEMPAQ XBC is a point-of-care device that can be used in patients home and analyze WBC and granulocytes by a single capillary blood drop. This study aims to investigate whether this new procedure increases the acceptability of clozapine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Psychiatric Hospital
      • Aarhus, Denmark, 8240
        • Psychiatric Center Aarhus
      • Copenhagen, Denmark
        • Psychiatric Center Copenhagen
      • Esbjerg, Denmark
        • Psychiatric Centre Esbjerg
      • Greve, Denmark, 2670
        • Psychiatric Center Roskilde
      • Odense, Denmark, 5000
        • Psychiatric Center Odense

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with clozapine

Description

Inclusion Criteria:

  • Treated with clozapine
  • Compliant with blood monitoring
  • Willing to give informed consent

Exclusion Criteria:

  • Prior case of agranulocytosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CHEMPAQ-venous-CHEMPAQ-venous
The two arms only differ in order of kind of blood samples.
Device: Venous blod sample
Regular venous blood sample withdrawn from the laboratory
Device: CHEMPAQ
Capillary blood sample analyzed by CHEMPAQ
Venous-CHEMPAQ-Venous-CHEMPAQ
The two arms only differ in order of kind of blood samples.
Device: Venous blod sample
Regular venous blood sample withdrawn from the laboratory
Device: CHEMPAQ
Capillary blood sample analyzed by CHEMPAQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain sensation
Time Frame: Monthly for four months
Pain sensation was measured using a visual analog scale (VAS)
Monthly for four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The benefits of CHEMPAQ
Time Frame: Monthly for four months
Caregivers and patients were asked about the benefits of using CHEMPAQ for hematological clozapine monitoring.
Monthly for four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aalborg Psychiatric Hospital

Investigators

  • Principal Investigator: Jimmi Nielsen, MD, Aalborg Psychiatric Hospital, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 21, 2010

First Submitted That Met QC Criteria

June 4, 2010

First Posted (Estimate)

June 7, 2010

Study Record Updates

Last Update Posted (Estimate)

November 6, 2011

Last Update Submitted That Met QC Criteria

November 4, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.5 - 01 MARCH2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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