SchizophreniaNCT03523741
Therapeutic Drug Monitoring for Individualized Clozapine Therapy
An observational study of Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the factors affecting the occurrence of adverse drug reactions (glucose and lipid metabolism abnormality, changes in liver function index and sleeping tendency) and clinical effects in schizophrenia patients with clozapine treatment Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Clozapine
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2018to 31 Dec 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are diagnosed with schizophrenia spectrum disorder and are expected to use clozapine for more than 57 days to treat or prevent recurrence of schizophrenia
Who may be able to join
- Patients who are diagnosed with schizophrenia spectrum disorder and are expected to use clozapine for more than 57 days to treat or prevent recurrence of schizophrenia
- Patients who are 19 years or older
- Patient who understands the contents of the clinical research and provide their written informed consent forms
Who cannot join
- Patients taking a drug that the researcher deems inappropriate before clozapine administration
- Patients who can not use an appropriate contraceptive method during the study period
- Patients whom the researcher deemed inappropriate for clinical research participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Seoyoung Kim, MD, 031-787-8219, zentiana0@gmail.com
About this study
Official title: A Clinical Trial to Investigate the Factors Affecting Adverse Drug Reactions and Clinical Efficacy of Clozapine in Korean
The purpose of this study is to evaluate the factors affecting the occurrence of adverse drug reactions (glucose and lipid metabolism abnormality, changes in liver function index and sleeping tendency) and clinical effects in schizophrenia patients with clozapine treatment
Read the detailed description
- The baseline tests (sleeping tendency assessment, clinical symptom and cognitive assessments, clinical laboratory tests, genotyping, exploratory biomarker tests, etc.) are conducted to the schizophrenia patients before initiation of the clozapine dosing.
- On day 15 and 57, the changes from baseline clinical symptom and cognitive function are assessed after clozapine treatment. Also, the occurrence of adverse drug reactions are evaluated. In addition, blood sample collections are performed for the assessment of clozapine and its metabolite levels.
- Conditions
- Schizophrenia
- Being tested
- Clozapine
- Keywords
- genetic polymorphism, pharmacodynamic variability, personalized pharmacotherapy, adverse drug reaction, quality of life
- Medical subject headings
- Schizophrenia, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClozapineDrug
Also called Clozapine treatment
Clozapine is administered orally according to individual prescribed dosing regimens.
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose and lipid metabolism abnormality
Change from baseline glucose and lipid profiles after clozapine administration
Measured: Change from baseline glucose and lipid profiles on Day 15, and 57
Liver function abnormality
Change from baseline liver function test
Measured: Change from baseline liver function test on Day 15, and 57
Sleeping tendency assessment
Epworth sleepiness scale (ESS).
- ESS is comprised of eight questions, each asking about the subject's likelihood of dozing off or falling asleep in a particular situation that is commonly met in daily life.
- Each ESS item score measures a particular "situational sleep propensity", and respondents use a four-point scale from 0 (no chance of dozing/falling asleep) to 3 (high chance of dozing/falling asleep) for each of the eight questions.
- The sum of eight item scores (the total ESS score) measures the subject's average sleep propensity across those different situations in daily life. A total ESS score of 16-24 points indicates severe excessive daytime sleepiness.
Measured: Change from baseline sleeping tendency assessment on Day 15, and 57
Secondary outcomes (2)
Cognitive function assessment
MCCB (MATRICS Consensus Cognitive Battery).
Measured: Change from baseline MCCB on Day 57, and 127
Clinical symptom assessment
Brief Psychiatric Rating Scale (BPRS).
- BPRS is a 24-item scale that measures psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour.
- Each symptom is rated on a scale from 1(not present) to 7(extremely severe).
- The sum of all 24 items is then calculated to a maximum score of 168. The higher the score, the more psychiatrically impaired the patient is.
Measured: Change from baseline BPRS on Day 15, and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start13 Jun 2018
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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.
- More trials run by Seoul National University HospitalThe 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Euitae Kim, Seoul National University Bundang Hospital
- Investigators
- Sang-In Park, Ph. D., Study chair, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523741
- Sponsor's protocol ID
- CLZ_01
- Status last verified
- Sep 2019
- First submitted
- 1 May 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Investigate the Factors Affecting Adverse Drug Reactions and Clinical Efficacy of Clozapine in Korean
- ClinicalTrials.gov ID
- NCT03523741
- Acronym / sponsor ID
- CLZ_01
- Conditions
- Schizophrenia
- Keywords
- genetic polymorphism, pharmacodynamic variability, personalized pharmacotherapy, adverse drug reaction, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 May 2018 (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 purpose of this study is to evaluate the factors affecting the occurrence of adverse drug reactions (glucose and lipid metabolism abnormality, changes in liver function index and sleeping tendency) and clinical effects in schizophrenia patients with clozapine treatment
Detailed description
- The baseline tests (sleeping tendency assessment, clinical symptom and cognitive assessments, clinical laboratory tests, genotyping, exploratory biomarker tests, etc.) are conducted to the schizophrenia patients before initiation of the clozapine dosing.
- On day 15 and 57, the changes from baseline clinical symptom and cognitive function are assessed after clozapine treatment. Also, the occurrence of adverse drug reactions are evaluated. In addition, blood sample collections are performed for the assessment of clozapine and its metabolite levels.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with schizophrenia spectrum disorder and are expected to use clozapine for more than 57 days to treat or prevent recurrence of schizophrenia
Key inclusion criteria (3 listed)
- Patients who are diagnosed with schizophrenia spectrum disorder and are expected to use clozapine for more than 57 days to treat or prevent recurrence of schizophrenia
- Patients who are 19 years or older
- Patient who understands the contents of the clinical research and provide their written informed consent forms
Key exclusion criteria (3 listed)
- Patients taking a drug that the researcher deems inappropriate before clozapine administration
- Patients who can not use an appropriate contraceptive method during the study period
- Patients whom the researcher deemed inappropriate for clinical research participation
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 |
|---|---|---|
| ClozapineAlso: Clozapine treatmentClozapine is administered orally according to individual prescribed dosing regimens. | Drug | – |
Primary outcome
Glucose and lipid metabolism abnormality
Time frame: Change from baseline glucose and lipid profiles on Day 15, and 57
Change from baseline glucose and lipid profiles after clozapine administration
Liver function abnormality
Time frame: Change from baseline liver function test on Day 15, and 57
Change from baseline liver function test
Sleeping tendency assessment
Time frame: Change from baseline sleeping tendency assessment on Day 15, and 57
Epworth sleepiness scale (ESS). * ESS is comprised of eight questions, each asking about the subject's likelihood of dozing off or falling asleep in a particular situation that is commonly met in daily life. * Each ESS item score measures a particular "situational sleep propensity", and respondents use a four-point scale from 0 (no chance of dozing/falling asleep) to 3 (high chance of dozing/falling asleep) for each of the eight questions. * The sum of eight item scores (the total ESS score) measures the subject's average sleep propensity across those different situations in daily life. A total ESS score of 16-24 points indicates severe excessive daytime sleepiness.
2 secondary outcomes
Cognitive function assessment
Time frame: Change from baseline MCCB on Day 57, and 127
Clinical symptom assessment
Time frame: Change from baseline BPRS on Day 15, and 57
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Sang-In Park, Ph. D. study chair
Kyung Hee University Hospital
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 Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Sep 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Euitae Kim, Ph. D. (+82-31-787-7435, euitae.kim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose and lipid metabolism abnormality (time frame: Change from baseline glucose and lipid profiles on Day 15, and 57). The study lists 3 primary outcomes in all. 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 24 Sep 2019.