Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics

June 11, 2009 updated by: Seoul National Hospital

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.

Study Overview

Status

Unknown

Conditions

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.

  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

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

DSM-IV diagnosis of schizophrenia

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
A, observatoin
inpatients and outpatients in Seoul National Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
metabolic syndrome
Time Frame: cross-sectional
cross-sectional

Secondary Outcome Measures

Outcome Measure
each factor of metabolic syndrome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National Hospital

Collaborators

Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Jong-il Lee, M.D., Seoul National Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

December 6, 2007

First Submitted That Met QC Criteria

December 6, 2007

First Posted (Estimate)

December 7, 2007

Study Record Updates

Last Update Posted (Estimate)

June 12, 2009

Last Update Submitted That Met QC Criteria

June 11, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • snh001
  • PMSPSTA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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