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NCT00569504 Clinical Trial

Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics

Schizophrenia Clinical Trial

Official title:
Prevalence of the Metabolic Syndrome in Patients With Schizophrenia Taking Antipsychotics

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00569504
Other study ID # snh001
Secondary ID PMSPSTA
Status Recruiting
Phase N/A
First received December 6, 2007
Last updated June 11, 2009
Start date December 2007
Est. completion date September 2009

Study information
Verified date June 2009
Source Seoul National Hospital
Contact Shi Hyun Kang, M.D.
Phone 82-2-2204-0326
Email drshe@hanmail.net
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date September 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

- schizophrenia or schizoaffective disorder

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National Hospital Seoul

Sponsors (2)
Lead Sponsor Collaborator
Seoul National Hospital Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary metabolic syndrome cross-sectional No
Secondary each factor of metabolic syndrome No
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