An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00448630

Purpose

The purpose of the study is to find and follow-up the metabolic syndrome parameters on patients administering atypical antipsychotics.

Condition	Intervention	Phase
Schizophrenia Metabolic Syndrome X	Other: No intervention	Phase IV

MedlinePlus related topics: Metabolic Syndrome Schizophrenia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Multi-Center, Non-Interventional, Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical (Second Generation) Antipsychotics

Further study details as provided by Pfizer:

Primary Outcome Measures:

To evaluate changes in metabolic syndrome parameters in schizophrenia patients treated with atypical antipsychotics [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the safety of atypical antipsychotic drugs. [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
To compare atypical antipsychotic drugs regarding their effects on the metabolic syndrome parameters and their safety profile [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride levels)

Enrollment:	327
Study Start Date:	October 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Atypical Antispychotics (or second generation antipsychotics) Patients with schizophrenia who are going to start a new treatment with atypical antipsychotics, ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, amisulpride.	Other: No intervention Non-interventional study

Detailed Description:

Group of patients using the same atypical anti-psychotic.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Female and male patients diagnosed as schizophrenia by DSM-IV criteria; Age between 18-55 years; Patients who started atypical antipsychotic drug treatment or patients who switched from the previous conventional or atypical antipsychotic treatment to another atypical antipsychotic drug treatment by the decision of their physicians in psychiatry clinics in state and university hospitals.

Criteria

Inclusion Criteria:

Female and male patients diagnosed as schizophrenia by the Diagnostic and Statistical Manual of Mental Disorders.
Age between 18-55 years
Patients who started atypical antipsychotic drug treatment or patients who switched from the previous conventional or atypical antipsychotic treatment to another atypical antipsychotic drug treatment by the decision of their physicians.

Exclusion Criteria:

Patients who are pregnant or considering pregnancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448630

Locations

Turkey
Pfizer Investigational Site
Istanbul, Turkey
Pfizer Investigational Site
Istanbul, Turkey, 34147
Pfizer Investigational Site
Adana, Turkey
Pfizer Investigational Site
Elazig, Turkey
Pfizer Investigational Site
Izmir, Turkey
Pfizer Investigational Site
Ankara, Turkey, 06200
Pfizer Investigational Site
Ankara, Turkey
Pfizer Investigational Site
Manisa, Turkey
Pfizer Investigational Site
Antakya, Turkey
Pfizer Investigational Site
Denizli, Turkey
Pfizer Investigational Site
Samsun, Turkey
Pfizer Investigational Site
Trabzon, Turkey
Pfizer Investigational Site
Konya, Turkey
Pfizer Investigational Site
Kayseri, Turkey
Pfizer Investigational Site
Bolu, Turkey
Pfizer Investigational Site
Eskisehir, Turkey
Pfizer Investigational Site
Trakya, Turkey
Turkey, Adana
Pfizer Investigational Site
Kurttepe, Adana, Turkey, 01360

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1281160
Study First Received:	March 16, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00448630
Health Authority:	Turkey: Ministry of Health, Directory of Pharmacies and Pharmaceuticals

Keywords provided by Pfizer:

Atypical antipsychotics, Metabolic syndrome, Safety

Study placed in the following topic categories:

Schizophrenia
Hyperinsulinism
Metabolic Diseases
Metabolic Syndrome X
Mental Disorders
Syndrome X

Psychotic Disorders
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Abdominal obesity metabolic syndrome
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009