Metabolic SyndromeNCT00569504
Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics
An observational study of Metabolic Syndrome and Schizophrenia, run by Seoul National Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to assess the cross-sectional prevalence of the metabolic syndrome in patients with schizophrenia taking antipsychotics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Schizophrenia
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2007to Sep 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: DSM-IV diagnosis of schizophrenia
Who may be able to join
- Patients taking a same antipsychotics at least more than one year
- schizophrenia or schizoaffective disorder
Who cannot join
- none
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: Prevalence of the Metabolic Syndrome in Patients With Schizophrenia Taking Antipsychotics
The purpose of this study is to assess the cross-sectional prevalence of the metabolic syndrome in patients with schizophrenia taking antipsychotics.
Read the detailed description
Schizophrenic patients taking any kind of antipsychotics for at least 1 year at the Seoul National Hospital will be participated in this study.
we are planning to enroll approximately 1000 patients with schizophrenia.
For each subject
- abdominal circumference
- body mass index
- lipid profile : TG, HDL-chlo, total chol
- systolic/diastolic blood pressure
- fasting blood glucose will be measured. we will calculate the rates of patients who meet the criteria for the Metabolic syndrome.
- Abdominal obesity : absolute criteria
- 2 or more of followings
- Triglyceride ≥ 150mg/dL or ongoing treatment
- HDL-cholesterol < 40mg/dL (men) HDL-cholesterol < 50mg/dL (female) or ongoing treatment
- Hypertension 130mmHg ≥ systolic 85mmHg ≥ diastolic or ongoing treatment
- FBS ≥ 100mg/dL or previous diagnosis of type II DM
- Conditions
- Metabolic Syndrome, Schizophrenia
- Keywords
- schizophrenia, antipsychotics, metabolic syndrome, prevalence
- Medical subject headings
- Metabolic Syndrome, Schizophrenia
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 |
|---|---|---|
| A, observatoin | inpatients and outpatients in Seoul National Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic syndrome
Measured: cross-sectional
Secondary outcomes (1)
each factor of metabolic syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startDec 2007
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National Hospital
- Sponsor type
- Other government
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Jong-il Lee, M.D., Study director, Seoul National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569504
- Sponsor's protocol ID
- snh001
- Other IDs
- PMSPSTA
- Status last verified
- Jun 2009
- First submitted
- 6 Dec 2007
- Last updated
- 12 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
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
- Prevalence of the Metabolic Syndrome in Patients With Schizophrenia Taking Antipsychotics
- ClinicalTrials.gov ID
- NCT00569504
- Acronym / sponsor ID
- snh001
- Conditions
- Metabolic Syndrome, Schizophrenia
- Keywords
- schizophrenia, antipsychotics, metabolic syndrome, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Seoul National HospitalOther government
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Study start
- Dec 2007
- Study completion
- Sep 2009 (estimated)
- First posted
- 7 Dec 2007 (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 purpose of this study is to assess the cross-sectional prevalence of the metabolic syndrome in patients with schizophrenia taking antipsychotics.
Detailed description
Schizophrenic patients taking any kind of antipsychotics for at least 1 year at the Seoul National Hospital will be participated in this study.
we are planning to enroll approximately 1000 patients with schizophrenia.
For each subject
- abdominal circumference
- body mass index
- lipid profile : TG, HDL-chlo, total chol
- systolic/diastolic blood pressure
- fasting blood glucose will be measured. we will calculate the rates of patients who meet the criteria for the Metabolic syndrome.
- Abdominal obesity : absolute criteria
- 2 or more of followings
- Triglyceride ≥ 150mg/dL or ongoing treatment
- HDL-cholesterol < 40mg/dL (men) HDL-cholesterol < 50mg/dL (female) or ongoing treatment
- Hypertension 130mmHg ≥ systolic 85mmHg ≥ diastolic or ongoing treatment
- FBS ≥ 100mg/dL or previous diagnosis of type II DM
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A, observatoin | – | –inpatients and outpatients in Seoul National Hospital |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- DSM-IV diagnosis of schizophrenia
Key inclusion criteria (2 listed)
- Patients taking a same antipsychotics at least more than one year
- schizophrenia or schizoaffective disorder
Key exclusion criteria (1 listed)
- none
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
metabolic syndrome
Time frame: cross-sectional
1 secondary outcome
each factor of metabolic syndrome
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.
Jong-il Lee, 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 Metabolic Syndrome and Schizophrenia, 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?
metabolic syndrome (time frame: cross-sectional). 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.