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NCT00448630 Clinical Trial

An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics

Schizophrenia Clinical Trial

— MESSAGE  

Official title:
A MULTI-CENTER, NON-INVASIVE OBSERVATIONAL STUDY OF METABOLIC SYNDROME PARAMETERS IN SCHIZOPHRENIC PATIENTS USING ATYPICAL ANTIPSYCHOTICS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00448630
Other study ID # A1281160
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 23, 2007
Est. completion date July 30, 2008

Study information
Verified date April 2022
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

Sampling Method Details: Group of patients using the same atypical anti-psychotic.

Recruitment information / eligibility
Status Completed
Enrollment 328
Est. completion date July 30, 2008
Est. primary completion date July 30, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Female and male patients diagnosed as schizophrenia by the Diagnostic and Statistical Manual of Mental Disorders. - Age between 18-45 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
Non-interventional study

Locations
Country Name City State
Turkey Adana Psychiatry and Neurology Hospital Adana
Turkey Cukurova University Scool of Medicine Adana
Turkey Pfizer Investigational Site Adana
Turkey Ankara Diskapi Training and Research Hospital Ankara
Turkey Ankara Numune Research Hospital Ankara
Turkey Ankara Numune Training and Research Hospital Department of Psychiatry Ankara
Turkey Ankara Oncology Research and Training Hospital Ankara
Turkey Pfizer Investigational Site Ankara
Turkey Pfizer Investigational Site Ankara
Turkey Antakya Mustafa Kemal University School of Medicine Antakya
Turkey Pfizer Investigational Site Antakya
Turkey Bolu Psychiatry and Neurology Hospital Bolu
Turkey Pfizer Investigational Site Bolu
Turkey Pamukkale University School Of Medicine Denizli
Turkey Pfizer Investigational Site Denizli
Turkey Elazig Mental Illness And Diseases Hospital Elazig
Turkey Pfizer Investigational Site Elazig
Turkey Eskisehir Osmangazi University Eskisehir
Turkey Pfizer Investigational Site Eskisehir
Turkey Bakirkoy Mental Health Hospital, First Clinic of Neurosis Istanbul
Turkey Bakirkoy Psychiatry and Neurology Hospital Istanbul
Turkey Bakirkoy Psychiatry and Neurology Hospital Istanbul
Turkey Cerrahpasa School of Medicine Istanbul
Turkey Erenkoy Psychology and neurology hospital Istanbul
Turkey Istanbul University Istanbul School of Medicine Istanbul
Turkey Marmara School of Medicine Istanbul
Turkey Pfizer Investigational Site Istanbul
Turkey Pfizer Investigational Site Istanbul
Turkey Sisli Etfal Research and training Hospital Istanbul
Turkey Vakif Gureba Hospital, Department of Psychiatry Istanbul
Turkey Ege University School Of Medicine Izmir
Turkey Pfizer Investigational Site Izmir
Turkey Kayseri Public Hospital Kayseri
Turkey Pfizer Investigational Site Kayseri
Turkey Pfizer Investigational Site Konya
Turkey Selcuk University Medical School Department of Psychiatry Konya
Turkey Adana Psychiatry and Neurology Hospital Kurttepe Adana
Turkey Pfizer Investigational Site Kurttepe Adana
Turkey Manisa Mental Illness And Diseases Hospital Manisa
Turkey Pfizer Investigational Site Manisa
Turkey 19 may University School of Medicine Samsun
Turkey Pfizer Investigational Site Samsun
Turkey Samsun Mental Illness And Diseases Hospital Samsun
Turkey Pfizer Investigational Site Trabzon
Turkey Trabzon Numune Research Hospital Trabzon
Turkey Pfizer Investigational Site Trakya
Turkey Trakya University School of Medicine Trakya

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Metabolic Syndrome Parameter Body Mass Index (BMI) Iterative mean Body Mass Index at time points. Baseline, 1 Month, 4 Months
Primary Metabolic Syndrome Parameter Body Weight Iterative measurement of body weight. Mean at time points. Baseline, 1 Month, 4 Months
Primary Metabolic Syndrome Parameter Waist Circumference Iterative measurement of waist circumference. Mean at timepoints. Baseline, 1 Month, 4 Months
Primary Metabolic Syndrome Parameter Fasting Blood Sugar Iterative measurement of fasting blood sugar. Mean at time points. Baseline, 1 Month, 4 Months
Primary Metabolic Syndrome Parameter Total Cholesterol Iterative measurement of total cholesterol. Mean at time points. Baseline, 1 Month, 4 Months
Primary Metabolic Syndrome Parameter Low Density Lipoprotein (LDL) Iterative measurement of LDL. Mean at time points Baseline, 1 Month, 4 Months
Primary Metabolic Syndrome Parameter High Density Lipoprotein (HDL) Iterative measurement of HDL. Mean at time points Baseline, 1 Month, 4 Months
Primary Metabolic Syndrome Parameter Triglycerides Iterative measurement of triglycerides. Mean at time points Baseline, 1 Month, 4 Months
Secondary Metabolic Syndrome Parameter BMI by Treatment Group Iterative measurement of BMI. Mean at time points. Baseline, 1 Month, 4 Months
Secondary Metabolic Syndrome Parameter Weight by Treatment Group Iterative measurement of weight. Mean at time points. Baseline, 1 Month, 4 Months
Secondary Metabolic Syndrome Parameter Waist Circumference by Treatment Group Iterative measurement of waist circumference. Mean at time points. Baseline, 1 Month, 4 Months
Secondary Metabolic Syndrome Parameter Triglycerides by Treatment Group Iterative measurement of triglycerides. Mean at time points. Baseline, 1 Month, 4 Months
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