Association of Multiple Genetic Polymorphisms With Clozapine-Associated Metabolic Change in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Cross-Sectional Study of the Association Between Multiple Genetic Polymorphisms and the Metabolic Side Effects in Patients With Schizophrenia Taking Clozapine More Than 1 Year

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00717509
• Other study ID #: snh003
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2008
• Last updated: June 9, 2009
• Start date: October 2007
• Est. completion date: October 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

We are going to investigate the association of multiple genetic polymorphisms with the metabolic side effects in patients with schizophrenia taking clozapine.

Description:

The use of antipsychotics, especially clozapine and olanzapine is associated with metabolic side effects, which put patients with schizophrenia at risk for cardiovascular morbidity or diabetes.

The prevalence of the metabolic syndrome was 53.8% of patients who taking clozapine. The high interindividual variability in antipsychotic-induced metabolic abnormalities suggests that genetic makeup is a possible determinant.

The genotypes of the multiple gene such as HTR2C, LEP, adrenergic receptor,PPAR,GNB3 are suggested to have associations with the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome) in patients using antipsychotics.

We are going to investigate whether those multiple genetic polymorphisms are associated with the metabolic side effects in patients taking clozapine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65

• who can understand and sign the informed consent

Exclusion Criteria:

• who refuse to participate this study

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Genetic Polymorphism
• Metabolic Syndrome
• Metabolic Syndrome X
• Schizophrenia

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The associations between multiplegenetic polymorphisms (HTR2C,leptin,adrenergic receptor,PPAR,GNB3) and the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome)		more than 1 year after starting clozapine	No