SchizophreniaPhase 4NCT02625103
The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring.
A Phase 4 study testing Blood sampling and Clozapine in people with Schizophrenia, run by Anders Fink-Jensen, MD, DMSci at 1 site in Denmark.
Trial summary
The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring should be drawn 12 hours post dose. The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine within the range of 10-14 hours after the last… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Blood sampling and Clozapine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to Feb 2016
- Phase
- Phase 4
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 < 65
- Diagnosed with schizophrenia according to the criteria of ICD10 (International Classification of Diseases, World Health Organization) or the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the American Psychiatric Association)
- Unchanged dose of clozapine for the last 30 days
- Usual time of clozapine evening-dose administration between 9 and 12 pm.
Who cannot join
- Significant drug or alcohol abuse that affects participation in this trial
- Non- or partial compliance of clozapine the day before the trial (assessed by interview)
- Unresponsive by telephone the evening before the trial
- Consumption of clozapine in the morning on the day of the trial
- Significant change in smoking habits within the last 30 days (assessed by interview)
- Significant change of caffeine intake within the last 7 days (assessed by interview)
Show all 9Show fewer
- Modified use of other antipsychotics within the last 30 days
- Within the last 30 days (7 days for hormone based contraceptives) changes in the use of other medications that can affect s- clozapine during the trial : ( fluvoxamine, ciprofloxacin, hormone based contraceptives, carbamazepine , phenytoin , rifampicin, omeprazole )
- Females who are pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring
The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring should be drawn 12 hours post dose.
The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine .
Read the detailed description
Several factors can influence s-clozapine and thereby the occurence of dose-related adverse reactions and level of treatment response. The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring are recommended to be drawn 12 hours post dose. Uncertainty regarding the timing of blood sampling and the individual pharmakokinetics for clozapine +/- 2 hours from the 12-hour timepoint, leads to uncertainty regarding the comparability of serum concentrations and the information hold within them.
The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine .
In addition we want to investigate if any of the following covariates might affect the change of s-clozapine and s-N-desmethyl-clozapine: Sex, age, BMI, co-medications, signs of infection, caffeine intake and smoking.
- Conditions
- Schizophrenia
- Being tested
- Blood sampling, Clozapine
- Keywords
- Schizophrenia, Clozapine, TDM, Serum Concentration
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
blood samples for s-clozapine and s-desmethyl-clozapine analysis are collected at 10, 11, 12, 13 and 14 hours post evening-clozapine-administration
ClozapineDrug
Also called Leponex
Registration of the exact time of drug administration. Also postponement of any morning clozapine administration until ended blood sampling.
| Study group | Role | What they receive |
|---|---|---|
| Clozapine | Experimental | treatment as usual: administration of clozapine between 9 and 12 pm. Blood sampling 10 -14 hours post drug administration Receives: Procedure: Blood sampling; Drug: Clozapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in serum-clozapine
Measured: 10 - 14 hours post drug administration
Secondary outcomes (1)
Percentage change in serum-clozapine (multiple shorter ranges)
Measured: < 10 -14 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders Fink-Jensen, MD, DMSci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
- Investigators
- Anders Fink-Jensen, MD, DMSci, Principal investigator, Psychiatric Centre Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625103
- Sponsor's protocol ID
- CLO-MEAS
- Other IDs
- 2015-002520-82, 2015
- Status last verified
- Feb 2016
- First submitted
- 13 Nov 2015
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring
- ClinicalTrials.gov ID
- NCT02625103
- Acronym / sponsor ID
- CLO-MEAS
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Clozapine, TDM, Serum Concentration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Anders Fink-Jensen, MD, DMSciUniversity, hospital or other
- Collaborators
- University of Copenhagen, Copenhagen University Hospital, Rigshospitalet
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Dec 2015 (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.
The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring should be drawn 12 hours post dose.
The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine .
Detailed description
Several factors can influence s-clozapine and thereby the occurence of dose-related adverse reactions and level of treatment response. The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring are recommended to be drawn 12 hours post dose. Uncertainty regarding the timing of blood sampling and the individual pharmakokinetics for clozapine +/- 2 hours from the 12-hour timepoint, leads to uncertainty regarding the comparability of serum concentrations and the information hold within them.
The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine .
In addition we want to investigate if any of the following covariates might affect the change of s-clozapine and s-N-desmethyl-clozapine: Sex, age, BMI, co-medications, signs of infection, caffeine intake and smoking.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clozapine | Experimental | Procedure: Blood sampling, Drug: Clozapinetreatment as usual: administration of clozapine between 9 and 12 pm. Blood sampling 10 -14 hours post drug administration |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 < 65
- Diagnosed with schizophrenia according to the criteria of ICD10 (International Classification of Diseases, World Health Organization) or the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the American Psychiatric Association)
- Unchanged dose of clozapine for the last 30 days
- Usual time of clozapine evening-dose administration between 9 and 12 pm.
Key exclusion criteria (9 listed)
- Significant drug or alcohol abuse that affects participation in this trial
- Non- or partial compliance of clozapine the day before the trial (assessed by interview)
- Unresponsive by telephone the evening before the trial
- Consumption of clozapine in the morning on the day of the trial
- Significant change in smoking habits within the last 30 days (assessed by interview)
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 |
|---|---|---|
| Blood samplingblood samples for s-clozapine and s-desmethyl-clozapine analysis are collected at 10, 11, 12, 13 and 14 hours post evening-clozapine-administration | Procedure or surgery | Clozapine |
| ClozapineAlso: LeponexRegistration of the exact time of drug administration. Also postponement of any morning clozapine administration until ended blood sampling. | Drug | Clozapine |
Primary outcome
Percentage change in serum-clozapine
Time frame: 10 - 14 hours post drug administration
1 secondary outcome
Percentage change in serum-clozapine (multiple shorter ranges)
Time frame: < 10 -14 hours post dose
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 25 Feb 2016.
- Individual participant dataSharing planned: No
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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.
Anders Fink-Jensen, MD, DMSci principal investigator
Psychiatric Centre Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood sampling and Clozapine in people with Schizophrenia, run by Anders Fink-Jensen, MD, DMSci at 1 site 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 4 inclusion and 9 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 25 Feb 2016. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage change in serum-clozapine (time frame: 10 - 14 hours post drug administration). 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 25 Feb 2016.