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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Seoul National Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Seoul National Hospital
ClinicalTrials.gov Identifier:
NCT00717509
First received: July 16, 2008
Last updated: June 9, 2009
Last verified: June 2009
  Purpose
We are going to investigate the association of multiple genetic polymorphisms with the metabolic side effects in patients with schizophrenia taking clozapine.

Condition
Schizophrenia
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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with schizophrenia taking clozapine more than 1 year
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • who refuse to participate this study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717509

Locations
Korea, Republic of
Seoul National Hospital
Seoul, Korea, Republic of, 139-757
Sponsors and Collaborators
Seoul National Hospital
Investigators
Study Director: Shi Hyun Kang, M.D. Seoul National Hospital
  More Information

Responsible Party: Shi Hyun Kang, Seoul National Hospital
ClinicalTrials.gov 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:
schizophrenia
metabolic side effect
clozapine
genetic polymorphism

Additional relevant MeSH terms:
Schizophrenia
Metabolic Syndrome X
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Clozapine
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

ClinicalTrials.gov processed this record on December 02, 2016