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

Completed

• Conditions: Metabolic Syndrome X; Schizophrenia

• Registration Number: NCT00448630
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2007-03-16
• Study First Submitted QC: 2007-03-16
• Study First Posted: 2007-03-19
• Study Start: 2007-10-23
• Primary Completion: 2008-07-30
• Study Completion: 2008-07-30
• Results First Submitted: 2009-07-27
• Results First Submitted QC: 2010-06-04
• Results First Posted: 2010-07-07
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic Syndrome Parameter Fasting Blood Sugar	Baseline, 1 Month, 4 Months	Iterative measurement of fasting blood sugar. Mean at time points.
Metabolic Syndrome Parameter Body Weight	Baseline, 1 Month, 4 Months	Iterative measurement of body weight. Mean at time points.
Metabolic Syndrome Parameter Waist Circumference	Baseline, 1 Month, 4 Months	Iterative measurement of waist circumference. Mean at timepoints.
Metabolic Syndrome Parameter Body Mass Index (BMI)	Baseline, 1 Month, 4 Months	Iterative mean Body Mass Index at time points.
Metabolic Syndrome Parameter Total Cholesterol	Baseline, 1 Month, 4 Months	Iterative measurement of total cholesterol. Mean at time points.
Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)	Baseline, 1 Month, 4 Months	Iterative measurement of LDL. Mean at time points
Metabolic Syndrome Parameter High Density Lipoprotein (HDL)	Baseline, 1 Month, 4 Months	Iterative measurement of HDL. Mean at time points
Metabolic Syndrome Parameter Triglycerides	Baseline, 1 Month, 4 Months	Iterative measurement of triglycerides. Mean at time points

Secondary Outcome Measures

Name	Time	Method
Metabolic Syndrome Parameter Triglycerides by Treatment Group	Baseline, 1 Month, 4 Months	Iterative measurement of triglycerides. Mean at time points.
Metabolic Syndrome Parameter BMI by Treatment Group	Baseline, 1 Month, 4 Months	Iterative measurement of BMI. Mean at time points.
Metabolic Syndrome Parameter Waist Circumference by Treatment Group	Baseline, 1 Month, 4 Months	Iterative measurement of waist circumference. Mean at time points.
Metabolic Syndrome Parameter Weight by Treatment Group	Baseline, 1 Month, 4 Months	Iterative measurement of weight. Mean at time points.

Trial Locations

Locations (28)

Adana Psychiatry and Neurology Hospital; 🇹🇷 Adana, Turkey

Pfizer Investigational Site; 🇹🇷 Trakya, Turkey

Cukurova University Scool of Medicine; 🇹🇷 Adana, Turkey

Ankara Oncology Research and Training Hospital; 🇹🇷 Ankara, 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

Antakya Mustafa Kemal University School of Medicine; 🇹🇷 Antakya, Turkey

Bolu Psychiatry and Neurology Hospital; 🇹🇷 Bolu, Turkey

Pamukkale University School Of Medicine; 🇹🇷 Denizli, Turkey

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