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

NCT ID: NCT01138618

Last Updated: 2011-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-05-31

Brief Summary

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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

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Conditions

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Schizophrenia

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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CHEMPAQ-venous-CHEMPAQ-venous

The two arms only differ in order of kind of blood samples.

Venous blod sample

Intervention Type DEVICE

Regular venous blood sample withdrawn from the laboratory

CHEMPAQ

Intervention Type DEVICE

Capillary blood sample analyzed by CHEMPAQ

Venous-CHEMPAQ-Venous-CHEMPAQ

The two arms only differ in order of kind of blood samples.

Venous blod sample

Intervention Type DEVICE

Regular venous blood sample withdrawn from the laboratory

CHEMPAQ

Intervention Type DEVICE

Capillary blood sample analyzed by CHEMPAQ

Interventions

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Venous blod sample

Regular venous blood sample withdrawn from the laboratory

Intervention Type DEVICE

CHEMPAQ

Capillary blood sample analyzed by CHEMPAQ

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Prior case of agranulocytosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg Psychiatric Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jimmi Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg Psychiatric Hospital, Aarhus University Hospital

Locations

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Psychiatric Center Roskilde

Greve, Greve, Denmark

Site Status

Aalborg Psychiatric Hospital

Aalborg, , Denmark

Site Status

Psychiatric Center Aarhus

Aarhus, , Denmark

Site Status

Psychiatric Center Copenhagen

Copenhagen, , Denmark

Site Status

Psychiatric Centre Esbjerg

Esbjerg, , Denmark

Site Status

Psychiatric Center Odense

Odense, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 3046553 (View on PubMed)

Other Identifiers

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1.5 - 01 MARCH2010

Identifier Type: -

Identifier Source: org_study_id