We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00717509
Recruitment Status : Unknown
Verified June 2009 by Seoul National Hospital.
Recruitment status was:  Recruiting
First Posted : July 17, 2008
Last Update Posted : June 12, 2009
Information provided by:
Seoul National Hospital

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

Condition or disease
Schizophrenia Metabolic Syndrome Genetic Polymorphism

Detailed 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.

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Study Start Date : October 2007
Primary Completion Date : January 2009
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine
U.S. FDA Resources

clozapine group
  • chronic schizophrenia
  • have been taking clozapine at leaset one year
  • without diabetes, pulmonary tuberculosis

Primary Outcome Measures :
  1. The associations between multiplegenetic polymorphisms (HTR2C,leptin,adrenergic receptor,PPAR,GNB3) and the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome) [ Time Frame: more than 1 year after starting clozapine ]

Biospecimen Retention:   Samples With DNA
peripheral blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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
patients with schizophrenia taking clozapine more than 1 year

Inclusion Criteria:

  • age 18-65
  • who can understand and sign the informed consent

Exclusion Criteria:

  • who refuse to participate this study

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): NCT00717509

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

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
Study Director: Shi Hyun Kang, M.D. Seoul National Hospital

Responsible Party: Shi Hyun Kang, Seoul National Hospital
ClinicalTrials.gov Identifier: NCT00717509     History of Changes
Other Study ID Numbers: snh003
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: June 12, 2009
Last Verified: June 2009

Keywords provided by Seoul National Hospital:
metabolic side effect
genetic polymorphism

Additional relevant MeSH terms:
Metabolic Syndrome X
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents