- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01324167
Effects of Gene Polymorphisms on Metabolic Features in Clozapine-treated Patients With Schizophrenia
March 25, 2011 updated by: Taipei Medical University WanFang Hospital
The investigators would like to know the association of gene polymorphisms and metabolic adversities in clozapine-treated patients with schizophrenia in Taiwan.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan
- Recruiting
- Taipei Medical University-WanFang Hospital
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Contact:
- Chun-Hsin Chen, MD
- Phone Number: 53961 886-2-29307930
- Email: chunhsin57@yahoo.com.tw
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
schizophrenia or schizoaffective disorder patients
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chun-Hsin Chen, MD, Taipei Medical University WanFang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Study Completion (Anticipated)
April 1, 2011
Study Registration Dates
First Submitted
March 24, 2011
First Submitted That Met QC Criteria
March 25, 2011
First Posted (Estimate)
March 28, 2011
Study Record Updates
Last Update Posted (Estimate)
March 28, 2011
Last Update Submitted That Met QC Criteria
March 25, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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