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

Completed

• Conditions: Schizophrenia
• Interventions: Device: Venous blod sample; Device: CHEMPAQ

• Registration Number: NCT01138618
• Lead Sponsor: University of Aarhus

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Primary Completion: 2010-12
• Study Completion: 2011-05
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-04
• Last Update Posted: 2011-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

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

Exclusion Criteria

• Prior case of agranulocytosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHEMPAQ-venous-CHEMPAQ-venous	Venous blod sample	The two arms only differ in order of kind of blood samples.
CHEMPAQ-venous-CHEMPAQ-venous	CHEMPAQ	The two arms only differ in order of kind of blood samples.
Venous-CHEMPAQ-Venous-CHEMPAQ	Venous blod sample	The two arms only differ in order of kind of blood samples.
Venous-CHEMPAQ-Venous-CHEMPAQ	CHEMPAQ	The two arms only differ in order of kind of blood samples.

Primary Outcome Measures

Name	Time	Method
Pain sensation	Monthly for four months	Pain sensation was measured using a visual analog scale (VAS)

Secondary Outcome Measures

Name	Time	Method
The benefits of CHEMPAQ	Monthly for four months	Caregivers and patients were asked about the benefits of using CHEMPAQ for hematological clozapine monitoring.

Trial Locations

Locations (6)

Psychiatric Center Copenhagen; 🇩🇰 Copenhagen, Denmark

Psychiatric Centre Esbjerg; 🇩🇰 Esbjerg, Denmark

Psychiatric Center Aarhus; 🇩🇰 Aarhus, Denmark

Psychiatric Center Roskilde; 🇩🇰 Greve, Denmark

Psychiatric Center Odense; 🇩🇰 Odense, Denmark

Aalborg Psychiatric Hospital; 🇩🇰 Aalborg, Denmark