SchizophreniaNCT00717509
Association of Multiple Genetic Polymorphisms With Clozapine-Associated Metabolic Change in Schizophrenia
An observational study of Schizophrenia and Metabolic Syndrome, run by Seoul National Hospital at 1 site in South Korea.
Trial summary
We are going to investigate the association of multiple genetic polymorphisms with the metabolic side effects in patients with schizophrenia taking clozapine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Metabolic Syndrome, Genetic Polymorphism
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2007to Oct 2009
- 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 with schizophrenia taking clozapine more than 1 year
Who may be able to join
- age 18-65
- who can understand and sign the informed consent
Who cannot join
- who refuse to participate this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National Hospital
Seoul, 139-757
Shi Hyun Kang, M.D., 82-2-2204-0326, drshe@hanmail.net
About this study
Official title: Cross-Sectional Study of the Association Between Multiple Genetic Polymorphisms and the Metabolic Side Effects in Patients With Schizophrenia Taking Clozapine More Than 1 Year
We are going to investigate the association of multiple genetic polymorphisms with the metabolic side effects in patients with schizophrenia taking clozapine.
Read the detailed description
The use of antipsychotics, especially clozapine and olanzapine is associated with metabolic side effects, which put patients with schizophrenia at risk for cardiovascular morbidity or diabetes.
The prevalence of the metabolic syndrome was 53.8% of patients who taking clozapine. The high interindividual variability in antipsychotic-induced metabolic abnormalities suggests that genetic makeup is a possible determinant.
The genotypes of the multiple gene such as HTR2C, LEP, adrenergic receptor,PPAR,GNB3 are suggested to have associations with the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome) in patients using antipsychotics.
We are going to investigate whether those multiple genetic polymorphisms are associated with the metabolic side effects in patients taking clozapine.
- Conditions
- Schizophrenia, Metabolic Syndrome, Genetic Polymorphism
- Keywords
- schizophrenia, metabolic side effect, clozapine, genetic polymorphism
- Medical subject headings
- Schizophrenia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| clozapine group | * chronic schizophrenia * have been taking clozapine at leaset one year * without diabetes, pulmonary tuberculosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The associations between multiplegenetic polymorphisms (HTR2C,leptin,adrenergic receptor,PPAR,GNB3) and the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome)
Measured: more than 1 year after starting clozapine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startOct 2007
- Primary completionJan 2009
- Study completionOct 2009 (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.
- 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National Hospital
- Sponsor type
- Other government
- Investigators
- Shi Hyun Kang, M.D., Study director, Seoul National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717509
- Sponsor's protocol ID
- snh003
- Status last verified
- Jun 2009
- First submitted
- 16 Jul 2008
- Last updated
- 12 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Study of the Association Between Multiple Genetic Polymorphisms and the Metabolic Side Effects in Patients With Schizophrenia Taking Clozapine More Than 1 Year
- ClinicalTrials.gov ID
- NCT00717509
- Acronym / sponsor ID
- snh003
- Conditions
- Schizophrenia, Metabolic Syndrome, Genetic Polymorphism
- Keywords
- schizophrenia, metabolic side effect, clozapine, genetic polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National HospitalOther government
- Study start
- Oct 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Oct 2009 (estimated)
- First posted
- 17 Jul 2008 (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.
We are going to investigate the association of multiple genetic polymorphisms with the metabolic side effects in patients with schizophrenia taking clozapine.
Detailed description
The use of antipsychotics, especially clozapine and olanzapine is associated with metabolic side effects, which put patients with schizophrenia at risk for cardiovascular morbidity or diabetes.
The prevalence of the metabolic syndrome was 53.8% of patients who taking clozapine. The high interindividual variability in antipsychotic-induced metabolic abnormalities suggests that genetic makeup is a possible determinant.
The genotypes of the multiple gene such as HTR2C, LEP, adrenergic receptor,PPAR,GNB3 are suggested to have associations with the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome) in patients using antipsychotics.
We are going to investigate whether those multiple genetic polymorphisms are associated with the metabolic side effects in patients taking clozapine.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clozapine group | – | –* chronic schizophrenia * have been taking clozapine at leaset one year * without diabetes, pulmonary tuberculosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with schizophrenia taking clozapine more than 1 year
Key inclusion criteria (2 listed)
- age 18-65
- who can understand and sign the informed consent
Key exclusion criteria (1 listed)
- who refuse to participate this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The associations between multiplegenetic polymorphisms (HTR2C,leptin,adrenergic receptor,PPAR,GNB3) and the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome)
Time frame: more than 1 year after starting clozapine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2009.
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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.
Shi Hyun Kang, M.D. study director
Seoul National 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 and Metabolic Syndrome, run by Seoul National 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 2 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: status not confirmed, as of the sponsor's last update on 12 Jun 2009. 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 Shi Hyun Kang, M.D. (82-2-2204-0326, drshe@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The associations between multiplegenetic polymorphisms (HTR2C,leptin,adrenergic receptor,PPAR,GNB3) and the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome) (time frame: more than 1 year after starting clozapine). 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 12 Jun 2009.