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Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Seoul National Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569504
First Posted: December 7, 2007
Last Update Posted: June 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Korea Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Seoul National Hospital
  Purpose
The purpose of this study is to assess the cross-sectional prevalence of the metabolic syndrome in patients with schizophrenia taking antipsychotics.

Condition
Metabolic Syndrome Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalence of the Metabolic Syndrome in Patients With Schizophrenia Taking Antipsychotics

Resource links provided by NLM:


Further study details as provided by Seoul National Hospital:

Primary Outcome Measures:
  • metabolic syndrome [ Time Frame: cross-sectional ]

Secondary Outcome Measures:
  • each factor of metabolic syndrome

Biospecimen Retention:   Samples Without DNA
blood sampling

Estimated Enrollment: 1000
Study Start Date: December 2007
Estimated Study Completion Date: September 2009
Groups/Cohorts
A, observatoin
inpatients and outpatients in Seoul National Hospital

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
DSM-IV diagnosis of schizophrenia
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569504


Contacts
Contact: Shi Hyun Kang, M.D. 82-2-2204-0326 drshe@hanmail.net

Locations
Korea, Republic of
Seoul National Hospital Recruiting
Seoul, Korea, Republic of, 139-757
Contact: Shi Hyun Kang, M.D.    82-2-2204-0326    drshe@hanmail.net   
Sponsors and Collaborators
Seoul National Hospital
Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Jong-il Lee, M.D. Seoul National Hospital
  More Information

Responsible Party: Shi Hyun Kang, Seoul National Hospital
ClinicalTrials.gov Identifier: NCT00569504     History of Changes
Other Study ID Numbers: snh001
PMSPSTA
First Submitted: December 6, 2007
First Posted: December 7, 2007
Last Update Posted: June 12, 2009
Last Verified: June 2009

Keywords provided by Seoul National Hospital:
schizophrenia
antipsychotics
metabolic syndrome
prevalence

Additional relevant MeSH terms:
Syndrome
Schizophrenia
Metabolic Syndrome X
Disease
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs