Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics

NCT ID: NCT00569504

Last Updated: 2009-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-09-30

Brief Summary

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The purpose of this study is to assess the cross-sectional prevalence of the metabolic syndrome in patients with schizophrenia taking antipsychotics.

Detailed Description

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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.

1. Abdominal obesity : absolute criteria
2. 2 or more of followings

1. Triglyceride ≥ 150mg/dL or ongoing treatment
2. HDL-cholesterol \< 40mg/dL (men) HDL-cholesterol \< 50mg/dL (female) or ongoing treatment
3. Hypertension 130mmHg ≥ systolic 85mmHg ≥ diastolic or ongoing treatment
4. FBS ≥ 100mg/dL or previous diagnosis of type II DM

Conditions

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Metabolic Syndrome Schizophrenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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A, observatoin

inpatients and outpatients in Seoul National Hospital

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients taking a same antipsychotics at least more than one year
* schizophrenia or schizoaffective disorder

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Seoul National Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Seoul National Hospital

Principal Investigators

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Jong-il Lee, M.D.

Role: STUDY_DIRECTOR

Seoul National Hospital

Locations

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Seoul National Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Shi Hyun Kang, M.D.

Role: CONTACT

82-2-2204-0326

Facility Contacts

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Shi Hyun Kang, M.D.

Role: primary

82-2-2204-0326

Other Identifiers

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PMSPSTA

Identifier Type: -

Identifier Source: secondary_id

snh001

Identifier Type: -

Identifier Source: org_study_id

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