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

This study has been completed.

Sponsor:

Collaborator:

Aalborg Psychiatric Hospital

Information provided by (Responsible Party):

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01138618

First received: May 21, 2010

Last updated: November 4, 2011

Last verified: November 2011

History of Changes

Purpose

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

Condition	Intervention
Schizophrenia	Device: Venous blod sample Device: CHEMPAQ


Study Type:	Observational
Study Design:	Observational Model: Case-Crossover Time Perspective: Prospective
Official Title:	Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Clozapine

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Pain sensation [ Time Frame: Monthly for four months ]
Pain sensation was measured using a visual analog scale (VAS)

Secondary Outcome Measures:

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.


Enrollment:	85
Study Start Date:	April 2010
Study Completion Date:	May 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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	Device: Venous blod sample Regular venous blood sample withdrawn from the laboratory Device: CHEMPAQ Capillary blood sample analyzed by CHEMPAQ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	Device: Venous blod sample Regular venous blood sample withdrawn from the laboratory Device: CHEMPAQ Capillary blood sample analyzed by CHEMPAQ

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients treated with clozapine

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Prior case of agranulocytosis

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138618

Locations


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

Sponsors and Collaborators

University of Aarhus

Aalborg Psychiatric Hospital

Investigators


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

More Information

Publications:

Kane J, Honigfeld G, Singer J, Meltzer H. Clozapine for the treatment-resistant schizophrenic. A double-blind comparison with chlorpromazine. Arch Gen Psychiatry. 1988 Sep;45(9):789-96.


Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01138618 History of Changes
Other Study ID Numbers:	1.5 - 01 MARCH2010
Study First Received:	May 21, 2010
Last Updated:	November 4, 2011

Keywords provided by University of Aarhus:


Clozapine hematological monitoring CHEMPAQ Granulocytes WBC

Additional relevant MeSH terms:


Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Clozapine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action	Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs GABA Antagonists GABA Agents

ClinicalTrials.gov processed this record on June 26, 2017

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