We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Effects of Gene Polymorphisms on Metabolic Features in Clozapine-treated Patients With 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: NCT01324167
Recruitment Status : Unknown
Verified March 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Recruiting
First Posted : March 28, 2011
Last Update Posted : March 28, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The investigators would like to know the association of gene polymorphisms and metabolic adversities in clozapine-treated patients with schizophrenia in Taiwan.

Condition or disease
Schizophrenia Schizoaffective Disorder

Detailed Description:
The atypical antipsychotics, such as olanzapine, risperidone, quetiapine, and ziprasidone, are effective in treating both the positive and negative symptoms in schizophrenia (Kelleher et al., 2002). However, atypical antipsychotics have been linked to several forms of morbidity, including obesity, hyperlipidemia, and type 2 diabetes mellitus (DM) (Bergman and Ader, 2005; Jin et al., 2004; Melkersson and Dahl, 2004). Compared with the general population, life expectancy in schizophrenic patients is shorter by as much as 20%, attributable to higher rates of suicide, accidental deaths, and natural causes such as cardiovascular disease and DM (Harris and Barraclough, 1998). Several studies have suggested that these metabolic abnormalities may lead to a greater vulnerability to cardiovascular disease and thus may contribute to the excessive mortality among schizophrenic patients.

Study Design

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Gene Polymorphisms on Metabolic Features in Clozapine-treated Patients With Schizophrenia
Study Start Date : May 2010
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Clozapine
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

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:   Non-Probability Sample
Study Population
schizophrenia or schizoaffective disorder patients
Criteria

Inclusion Criteria:

  • fulfilled DSM-IV criteria of schizophrenia or schizoaffective disorder
  • 18-65 year of age
  • receiving clozapine for at least 6 months

Exclusion Criteria:

  • diabetes mellitus patients
Contacts and Locations

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): NCT01324167


Contacts
Contact: Chun-Hsin Chen, MD 886-2-29307930 ext 53961 chunhsin57@yahoo.com.tw

Locations
Taiwan
Taipei Medical University-WanFang Hospital Recruiting
Taipei, Taiwan
Contact: Chun-Hsin Chen, MD    886-2-29307930 ext 53961    chunhsin57@yahoo.com.tw   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Chun-Hsin Chen, MD Taipei Medical University WanFang Hospital
More Information

Responsible Party: Chun-Hsin Chen, Department of Psychiatry, WanFang Hospital
ClinicalTrials.gov Identifier: NCT01324167     History of Changes
Other Study ID Numbers: 99037
First Posted: March 28, 2011    Key Record Dates
Last Update Posted: March 28, 2011
Last Verified: March 2011

Keywords provided by Taipei Medical University WanFang Hospital:
schizophrenia
schizoaffective disorder

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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