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

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

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

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

Conditions
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Schizophrenia, Metabolic Syndrome X

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atypical Antispychotics (or second generation antipsychotics)<br>Patients with schizophrenia who are currently receiving or are going to start a new treatment with atypical antipsychotics, ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, amisulpride. | Other: No intervention<br>* Non-interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Syndrome Parameter BMI by Treatment Group | Iterative measurement of BMI. Mean at time points. | Baseline, 1 Month, 4 Months | 
| Metabolic Syndrome Parameter Weight by Treatment Group | Iterative measurement of weight. Mean at time points. | Baseline, 1 Month, 4 Months | 
| Metabolic Syndrome Parameter Waist Circumference by Treatment Group | Iterative measurement of waist circumference. Mean at time points. | Baseline, 1 Month, 4 Months | 
| Metabolic Syndrome Parameter Triglycerides by Treatment Group | Iterative measurement of triglycerides. Mean at time points. | Baseline, 1 Month, 4 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atypical antipsychotics, Metabolic syndrome, Safety