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Hematological Clozapine Monitoring With a Point-of-care Device (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:

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 ] [ Designated as safety issue: No ]
    Pain sensation was measured using a visual analog scale (VAS)


Secondary Outcome Measures:
  • The benefits of CHEMPAQ [ Time Frame: Monthly for four months ] [ Designated as safety issue: No ]
    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Regular venous blood sample withdrawn from the laboratory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Regular venous blood sample withdrawn from the laboratory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
Genders Eligible for Study:   Both
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
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:

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
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Clozapine
hematological monitoring
CHEMPAQ
Granulocytes
WBC

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents

ClinicalTrials.gov processed this record on May 23, 2013