Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ) (CHEMPAQ)
This study has been completed.
Sponsor:
University of Aarhus
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
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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:
Genetics Home Reference related topics:
schizophrenia
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Regular venous blood sample withdrawn from the laboratory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 (Adult) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138618
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 Spectrum and Other Psychotic Disorders Mental Disorders Clozapine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs GABA Antagonists GABA Agents |
ClinicalTrials.gov processed this record on September 29, 2016