Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Seoul National Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:
Seoul National Hospital
ClinicalTrials.gov Identifier:
NCT00569504
First received: December 6, 2007
Last updated: June 11, 2009
Last verified: June 2009

December 6, 2007
June 11, 2009
December 2007
Not Provided
metabolic syndrome [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT00569504 on ClinicalTrials.gov Archive Site
each factor of metabolic syndrome [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics
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.

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
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

blood sampling

Probability Sample

DSM-IV diagnosis of schizophrenia

  • Metabolic Syndrome
  • Schizophrenia
Not Provided
A, observatoin
inpatients and outpatients in Seoul National Hospital
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
September 2009
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Both
18 Years to 65 Years
No
Contact: Shi Hyun Kang, M.D. 82-2-2204-0326 drshe@hanmail.net
Korea, Republic of
 
NCT00569504
snh001, PMSPSTA
No
Shi Hyun Kang, Seoul National Hospital
Seoul National Hospital
Korea Otsuka Pharmaceutical Co.,Ltd.
Study Director: Jong-il Lee, M.D. Seoul National Hospital
Seoul National Hospital
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP