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Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics

Sponsor
Seoul National Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00569504
Collaborator
Korea Otsuka Pharmaceutical Co., Ltd. (Industry)
1,000
Enrollment
1
Location
21
Duration (Months)
47.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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

    3. Triglyceride ≥ 150mg/dL or ongoing treatment

    4. HDL-cholesterol < 40mg/dL (men) HDL-cholesterol < 50mg/dL (female) or ongoing treatment

    5. Hypertension 130mmHg ≥ systolic 85mmHg ≥ diastolic or ongoing treatment

    6. FBS ≥ 100mg/dL or previous diagnosis of type II DM

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence of the Metabolic Syndrome in Patients With Schizophrenia Taking Antipsychotics
    Study Start Date :
    Dec 1, 2007
    Anticipated Study Completion Date :
    Sep 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    A, observatoin

    inpatients and outpatients in Seoul National Hospital

    Outcome Measures

    Primary Outcome Measures

    1. metabolic syndrome [cross-sectional]

    Secondary Outcome Measures

    1. each factor of metabolic syndrome []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients taking a same antipsychotics at least more than one year

    • schizophrenia or schizoaffective disorder

    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National Hospital Seoul Korea, Republic of 139-757

    Sponsors and Collaborators

    • Seoul National Hospital
    • Korea Otsuka Pharmaceutical Co., Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00569504
    Other Study ID Numbers:
    • snh001
    • PMSPSTA
    First Posted:
    Dec 7, 2007
    Last Update Posted:
    Jun 12, 2009
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    schizophrenia
    antipsychotics
    metabolic syndrome
    prevalence
    Additional relevant MeSH terms:
    Metabolic Syndrome
    Syndrome
    Schizophrenia

    Study Results

    No Results Posted as of Jun 12, 2009