SchizophreniaCHEMPAQNCT01138618
Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)
An observational study of Schizophrenia, run by University of Aarhus at 6 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Venous blod sample and CHEMPAQ
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- 6 sitesDenmark
- Study dates
- Apr 2010to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with clozapine
Who may be able to join
- Treated with clozapine
- Compliant with blood monitoring
- Willing to give informed consent
Who cannot join
- Prior case of agranulocytosis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Aalborg Psychiatric Hospital
Aalborg, 9000
Psychiatric Center Aarhus
Aarhus, 8240
Psychiatric Center Copenhagen
Copenhagen
Psychiatric Centre Esbjerg
Esbjerg
Psychiatric Center Roskilde
Greve, Greve, 2670
Psychiatric Center Odense
Odense, 5000
About this study
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
- Conditions
- Schizophrenia
- Being tested
- Venous blod sample, CHEMPAQ
- Keywords
- Clozapine, hematological monitoring, CHEMPAQ, Granulocytes, WBC
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blod sampleDevice
Regular venous blood sample withdrawn from the laboratory
CHEMPAQDevice
Capillary blood sample analyzed by CHEMPAQ
| Study group | Role | What they receive |
|---|---|---|
| CHEMPAQ-venous-CHEMPAQ-venous | The two arms only differ in order of kind of blood samples. Receives: Device: Venous blod sample; Device: CHEMPAQ | |
| Venous-CHEMPAQ-Venous-CHEMPAQ | The two arms only differ in order of kind of blood samples. Receives: Device: Venous blod sample; Device: CHEMPAQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensation
Pain sensation was measured using a visual analog scale (VAS)
Measured: Monthly for four months
Secondary outcomes (1)
The benefits of CHEMPAQ
Caregivers and patients were asked about the benefits of using CHEMPAQ for hematological clozapine monitoring.
Measured: Monthly for four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg Psychiatric Hospital
- Responsible party
- Sponsor
- Investigators
- Jimmi Nielsen, MD, Principal investigator, Aalborg Psychiatric Hospital, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138618
- Sponsor's protocol ID
- 1.5 - 01 MARCH2010
- Acronym
- CHEMPAQ
- Status last verified
- Nov 2011
- First submitted
- 21 May 2010
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 3046553
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)
- ClinicalTrials.gov ID
- NCT01138618
- Acronym / sponsor ID
- CHEMPAQ / 1.5 - 01 MARCH2010
- Conditions
- Schizophrenia
- Keywords
- Clozapine, hematological monitoring, CHEMPAQ, Granulocytes, WBC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg Psychiatric Hospital
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHEMPAQ-venous-CHEMPAQ-venous | – | Device: Venous blod sample, Device: CHEMPAQThe two arms only differ in order of kind of blood samples. |
| Venous-CHEMPAQ-Venous-CHEMPAQ | – | Device: Venous blod sample, Device: CHEMPAQThe two arms only differ in order of kind of blood samples. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with clozapine
Key inclusion criteria (3 listed)
- Treated with clozapine
- Compliant with blood monitoring
- Willing to give informed consent
Key exclusion criteria (1 listed)
- Prior case of agranulocytosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blod sampleRegular venous blood sample withdrawn from the laboratory | Device | CHEMPAQ-venous-CHEMPAQ-venous, Venous-CHEMPAQ-Venous-CHEMPAQ |
| CHEMPAQCapillary blood sample analyzed by CHEMPAQ | Device | CHEMPAQ-venous-CHEMPAQ-venous, Venous-CHEMPAQ-Venous-CHEMPAQ |
Primary outcome
Pain sensation
Time frame: Monthly for four months
Pain sensation was measured using a visual analog scale (VAS)
1 secondary outcome
The benefits of CHEMPAQ
Time frame: Monthly for four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
- Background: PubMed 3046553Kane 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jimmi Nielsen, MD principal investigator
Aalborg Psychiatric Hospital, Aarhus University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by University of Aarhus at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain sensation (time frame: Monthly for four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01138618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2011.