NCT01477918

Brief Summary

The aim of this study is to examine the prevalence of the Metabolic syndrome(MetS) in Korean patients with schizophrenia. Primary objective:

  • To investigate the prevalence of the MetS in Korean patients with schizophrenia Secondary objectives:
  • To compare the prevalence of the MetS among 3 groups according to antipsychotics: typical antipsychotic monotherapy group, atypical antipsychotic monotherapy group, 2 or more antipsychotics group (polypharmacy)

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

First QC Date

November 20, 2011

Last Update Submit

November 22, 2011

Conditions

SchizophreniaMetabolic Syndrome

Keywords

prevalenceKorea

Outcome Measures

Primary Outcomes (1)

  • prevalence of metabolic syndrome (MetS)

    MetS will be diagnosed according to NCEP ATP III with the Asian-Pacific abdominal obesity criterion (≥90 cm in men, ≥85 cm in women) 3 or more of the following criteria 1. fasting plasma glucose \>= 100 mg/dl or drug use to treat elevated glucose 2. serum triglyceride (TG) \>= 150 mg/dl or drug use to treat elevated TG 3. HDL cholesterol level \< 40mg /dl in males, \< 50 mg/dl in female or drug use to treat low HDL 4. Systolic BP \>=130 mmHg, diastolic BP \>=85 or drug use to treat hypertension 5. Abdominal obesity : above described

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include all patients that met the following criteria: 1. Diagnosis of schizophrenia according to DSM-IV-TR 2. Age between 18-65 years To obtain the representative results for the prevalence of the MetS in schizophrenic patients stratified age and gender, we plan to evaluate about one thousand patients in twenty nationwide centers. 1. 20 centers were selected to provide the representative results of prevalence of the MetS 2. 50 patients in each center were consecutively enrolled

You may qualify if:

  • Diagnosis of schizophrenia according to DSM-IV-TR
  • Age between 18-65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan medical center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

SchizophreniaMetabolic Syndrome

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Yeon-Ho Joo, Ph.D.

CONTACT

82-2-3010-3412jooyh@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 20, 2011

First Posted

November 23, 2011

Study Start

December 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

KR(1)