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

Schizophrenia Clinical Trial

— CHEMPAQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138618
• Other study ID #: 1.5 - 01 MARCH2010
• Status: Completed
• Phase: N/A
• First received: May 21, 2010
• Last updated: November 4, 2011
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Treated with clozapine

• Compliant with blood monitoring

• Willing to give informed consent

Exclusion Criteria:

• Prior case of agranulocytosis

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• Venous blod sample
Regular venous blood sample withdrawn from the laboratory
• CHEMPAQ
Capillary blood sample analyzed by CHEMPAQ

Locations

Country	Name	City	State
Denmark	Aalborg Psychiatric Hospital	Aalborg
Denmark	Psychiatric Center Aarhus	Aarhus
Denmark	Psychiatric Center Copenhagen	Copenhagen
Denmark	Psychiatric Centre Esbjerg	Esbjerg
Denmark	Psychiatric Center Roskilde	Greve
Denmark	Psychiatric Center Odense	Odense

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg Psychiatric Hospital

Country where clinical trial is conducted

Denmark, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain sensation	Pain sensation was measured using a visual analog scale (VAS)	Monthly for four months	No
Secondary	The benefits of CHEMPAQ	Caregivers and patients were asked about the benefits of using CHEMPAQ for hematological clozapine monitoring.	Monthly for four months	No