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

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
Information provided by:
Seoul National Hospital Identifier:
First received: July 16, 2008
Last updated: June 9, 2009
Last verified: June 2009

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

Metabolic Syndrome
Genetic Polymorphism

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Seoul National Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

peripheral blood

Estimated Enrollment: 150
Study Start Date: October 2007
Estimated Study Completion Date: October 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
clozapine group
  • chronic schizophrenia
  • have been taking clozapine at leaset one year
  • without diabetes, pulmonary tuberculosis

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00717509

Contact: Shi Hyun Kang, M.D. 82-2-2204-0326

Korea, Republic of
Seoul National Hospital Recruiting
Seoul, Korea, Republic of, 139-757
Contact: Shi Hyun Kang, M.D.    82-2-2204-0326   
Sponsors and Collaborators
Seoul National Hospital
Study Director: Shi Hyun Kang, M.D. Seoul National Hospital
  More Information

No publications provided

Responsible Party: Shi Hyun Kang, Seoul National Hospital Identifier: NCT00717509     History of Changes
Other Study ID Numbers: snh003
Study First Received: July 16, 2008
Last Updated: June 9, 2009
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Metabolism Disorders
Insulin Resistance
Mental Disorders
Metabolic Diseases
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents processed this record on November 27, 2014