Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)
CHEMPAQ
1 other identifier
observational
85
1 country
6
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2010
6 active sites
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
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 21, 2010
CompletedFirst Posted
Study publicly available on registry
June 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedNovember 7, 2011
November 1, 2011
8 months
May 21, 2010
November 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain sensation
Pain sensation was measured using a visual analog scale (VAS)
Monthly for four months
Secondary Outcomes (1)
The benefits of CHEMPAQ
Monthly for four months
Study Arms (2)
CHEMPAQ-venous-CHEMPAQ-venous
The two arms only differ in order of kind of blood samples.
Venous-CHEMPAQ-Venous-CHEMPAQ
The two arms only differ in order of kind of blood samples.
Interventions
Regular venous blood sample withdrawn from the laboratory
Capillary blood sample analyzed by CHEMPAQ
Eligibility Criteria
Patients treated with clozapine
You may qualify if:
- Treated with clozapine
- Compliant with blood monitoring
- Willing to give informed consent
You may not qualify if:
- Prior case of agranulocytosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aalborg Psychiatric Hospitalcollaborator
Study Sites (6)
Psychiatric Center Roskilde
Greve, Greve, 2670, Denmark
Aalborg Psychiatric Hospital
Aalborg, 9000, Denmark
Psychiatric Center Aarhus
Aarhus, 8240, Denmark
Psychiatric Center Copenhagen
Copenhagen, Denmark
Psychiatric Centre Esbjerg
Esbjerg, Denmark
Psychiatric Center Odense
Odense, 5000, Denmark
Related Publications (1)
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. doi: 10.1001/archpsyc.1988.01800330013001.
PMID: 3046553BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jimmi Nielsen, MD
Aalborg Psychiatric Hospital, Aarhus University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2010
First Posted
June 7, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2010
Study Completion
May 1, 2011
Last Updated
November 7, 2011
Record last verified: 2011-11