Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics - Full Text View

Sponsors and Collaborators:	Seoul National Hospital Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:	Seoul National Hospital
ClinicalTrials.gov Identifier:	NCT00569504

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

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

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

Further study details as provided by Seoul National Hospital:

Primary Outcome Measures:

Abdominal obesity [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
Triglyceride ≥ 150mg/dL [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
HDL-cholesterol ＜ 40mg/dL(men), ＜ 50mg/dL(female) [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
130mmHg ≥ systolic BP, 85mmHg ≥ diastolic BP [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
FBS ≥ 100mg/dL or previous diagnosis of type II DM [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

no [ Time Frame: no ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

blood sampling

Estimated Enrollment:	1000
Study Start Date:	December 2007
Estimated Study Completion Date:	September 2008

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 critera for the Metabolic syndrome.

Abdominal obesity : absolute criteria
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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

DSM-IV diagnosis of schizophrenia

Criteria

Inclusion Criteria:

Patients taking a same antipsychotics more than one year

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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:	Seoul National Hospital ( Shi Hyun Kang )
Study ID Numbers:	snh001, PMSPSTA
Study First Received:	December 6, 2007
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00569504
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National Hospital:

schizophrenia
antipsychotics
metabolic syndrome
prevalence

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 15, 2009