A MULTI-CENTER, NON-INVASIVE OBSERVATIONAL STUDY OF METABOLIC SYNDROME PARAMETERS IN SCHIZOPHRENIC PATIENTS USING ATYPICAL ANTIPSYCHOTICS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 328
- Locations
- 28
- Primary Endpoint
- Metabolic Syndrome Parameter Fasting Blood Sugar
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Metabolic Syndrome Parameter Fasting Blood Sugar
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of fasting blood sugar. Mean at time points.
Metabolic Syndrome Parameter Body Weight
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of body weight. Mean at time points.
Metabolic Syndrome Parameter Waist Circumference
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of waist circumference. Mean at timepoints.
Metabolic Syndrome Parameter Body Mass Index (BMI)
Time Frame: Baseline, 1 Month, 4 Months
Iterative mean Body Mass Index at time points.
Metabolic Syndrome Parameter Total Cholesterol
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of total cholesterol. Mean at time points.
Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of LDL. Mean at time points
Metabolic Syndrome Parameter High Density Lipoprotein (HDL)
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of HDL. Mean at time points
Metabolic Syndrome Parameter Triglycerides
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of triglycerides. Mean at time points
Secondary Outcomes
- Metabolic Syndrome Parameter Weight by Treatment Group(Baseline, 1 Month, 4 Months)
- Metabolic Syndrome Parameter Triglycerides by Treatment Group(Baseline, 1 Month, 4 Months)
- Metabolic Syndrome Parameter BMI by Treatment Group(Baseline, 1 Month, 4 Months)
- Metabolic Syndrome Parameter Waist Circumference by Treatment Group(Baseline, 1 Month, 4 Months)