Patients Prescribed ClozapineNCT05422131
Clozapine Therapy Sample Collection - Method Comparison Study
An observational study of Patients Prescribed Clozapine, run by Saladax Biomedical, Inc. at 1 site in United States.
Trial summary
The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psychiatry Clozapine… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients Prescribed Clozapine
- What is being tested?
- MyCare Insite Clozapine Test
- Type of treatment
- Medical device
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2022to 16 May 2023
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A minimum of 150 unique subjects are required for the collection of at least 150 of each a capillary fingerstick blood, venous serum, and venous K2EDTA blood samples. A subset of at least 75 subjects will require two fingerstick blood samples. Subjects consisting of males and females, at least 21 years of age or older, who meet the protocol Inclusion / Exclusion criteria as described below.
Who may be able to join
- Study subjects must meet all the following criteria to be eligible for enrollment into the study:
- Female or male subjects 21 years of age or older;
- Current treatment with clozapine with documentation of diagnosed psychiatric condition requiring treatment;
- Capable of understanding and complying with parameters as outlined in the protocol;
- Capable of understanding and providing written informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any screening or study specific procedures.
Who cannot join
- 1. Female or male subjects under the 21 years of age; 2. Unwilling or unable to follow protocol requirements or to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saladax Biomedical, Inc.
Bethlehem, Pennsylvania, 18015
About this study
Official title: Collection of Capillary Fingerstick Blood, Venous Serum, and Venous K2EDTA Blood Samples From Subjects Receiving Clozapine Therapy
The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psychiatry Clozapine Assay Kit manufactured by SBI, and the point of care MyCare Insite Clozapine Test manufactured by SBI. Clozapine measurements obtained using the MyCare Insite Clozapine Test are intended for investigational purposes only and shall not be used in the management of patients receiving clozapine therapy.
- Conditions
- Patients Prescribed Clozapine
- Being tested
- MyCare Insite Clozapine Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyCare Insite Clozapine TestDevice
The MyCare Insite Clozapine Test is a 2 reagent system designed to evaluate the level of antipsychotic drug clozapine in a patients blood using the near patient device the MyCare Insite Analyser.
| Study group | Role | What they receive |
|---|---|---|
| Patients Prescribed Clozapine | Not described Receives: Device: MyCare Insite Clozapine Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sample Analysis - Method Comparision
Determine if the MyCare Insite Clozapine Test returns blood level results which are equivalent to results obtained using the MyCare Pyschiatry Assay Kit and LC-MS
Measured: October, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start12 Nov 2022
- Primary completion25 Jan 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Prescribed ClozapineStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saladax Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwell Health, University of Maryland, Baltimore
- Responsible party
- Sponsor
- Investigators
- Robert Christenson, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422131
- Sponsor's protocol ID
- SBI-CLZ-002
- Status last verified
- May 2023
- First submitted
- 14 Jun 2022
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Capillary Fingerstick Blood, Venous Serum, and Venous K2EDTA Blood Samples From Subjects Receiving Clozapine Therapy
- ClinicalTrials.gov ID
- NCT05422131
- Acronym / sponsor ID
- SBI-CLZ-002
- Conditions
- Patients Prescribed Clozapine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Saladax Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Northwell Health, University of Maryland, Baltimore
- Study start
- 12 Nov 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 16 Jun 2022 (actual)
- 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.
The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psychiatry Clozapine Assay Kit manufactured by SBI, and the point of care MyCare Insite Clozapine Test manufactured by SBI. Clozapine measurements obtained using the MyCare Insite Clozapine Test are intended for investigational purposes only and shall not be used in the management of patients receiving clozapine therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Prescribed Clozapine | – | Device: MyCare Insite Clozapine Test |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of 150 unique subjects are required for the collection of at least 150 of each a capillary fingerstick blood, venous serum, and venous K2EDTA blood samples. A subset of at least 75 subjects will require two fingerstick blood samples. Subjects consisting of males and females, at least 21 years of age or older, who meet the protocol Inclusion / Exclusion criteria as described below.
Key inclusion criteria (5 listed)
- Study subjects must meet all the following criteria to be eligible for enrollment into the study:
Key exclusion criteria (1 listed)
- 1. Female or male subjects under the 21 years of age; 2. Unwilling or unable to follow protocol requirements or to give written informed consent.
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 |
|---|---|---|
| MyCare Insite Clozapine TestThe MyCare Insite Clozapine Test is a 2 reagent system designed to evaluate the level of antipsychotic drug clozapine in a patients blood using the near patient device the MyCare Insite Analyser. | Device | Patients Prescribed Clozapine |
Primary outcome
Sample Analysis - Method Comparision
Time frame: October, 2022
Determine if the MyCare Insite Clozapine Test returns blood level results which are equivalent to results obtained using the MyCare Pyschiatry Assay Kit and LC-MS
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 18 May 2023.
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.
Robert Christenson principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Prescribed Clozapine, run by Saladax Biomedical, Inc. at 1 site in United States.
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 5 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 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Sample Analysis - Method Comparision (time frame: October, 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2023.