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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01324167
Other study ID # 99037
Secondary ID
Status Recruiting
Phase N/A
First received March 24, 2011
Last updated March 25, 2011
Start date May 2010
Est. completion date April 2011

Study information

Verified date March 2011
Source Taipei Medical University WanFang Hospital
Contact Chun-Hsin Chen, MD
Phone 886-2-29307930
Email chunhsin57@yahoo.com.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date April 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
Taiwan Taipei Medical University-WanFang Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

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