Metabolic Syndrome X, Schizophrenia
Conditions
Keywords
Atypical antipsychotics, Metabolic syndrome, Safety
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.
Interventions
OTHERNo intervention
Non-interventional study
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Syndrome Parameter Triglycerides | Baseline, 1 Month, 4 Months | Iterative measurement of triglycerides. 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 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 Waist Circumference | Baseline, 1 Month, 4 Months | Iterative measurement of waist circumference. Mean at timepoints. |
| 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 Mass Index (BMI) | Baseline, 1 Month, 4 Months | Iterative mean Body Mass Index at time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Syndrome Parameter Weight by Treatment Group | Baseline, 1 Month, 4 Months | Iterative measurement of weight. 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 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. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Subjects diagnosed with schizophrenia who have been using or recommended to use atypical antipsychotic drugs.
Participants by arm
| Arm | Count |
|---|---|
| Atypical Antipsychotic Treatment Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors. | 328 |
| Total | 328 |
Baseline characteristics
| Characteristic | Atypical Antipsychotic Treatment |
|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment Turkey | 328 participants |
| Sex: Female, Male Female | 206 Participants |
| Sex: Female, Male Male | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 57 | 14 / 64 | 5 / 23 | 27 / 60 | 12 / 50 | 9 / 41 | 33 / 33 |
| serious Total, serious adverse events | 0 / 57 | 0 / 64 | 0 / 23 | 0 / 60 | 0 / 50 | 0 / 41 | 0 / 33 |
Outcome results
Primary
Metabolic Syndrome Parameter Body Mass Index (BMI)
Iterative mean Body Mass Index at time points.
Time frame: Baseline, 1 Month, 4 Months
Population: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Body Mass Index (BMI) | Baseline | 26.3 kg/m*m (kilograms per meter squared) | Standard Deviation 16.7 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Body Mass Index (BMI) | 1 Month | 26.6 kg/m*m (kilograms per meter squared) | Standard Deviation 16.3 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Body Mass Index (BMI) | 4 Months | 26.9 kg/m*m (kilograms per meter squared) | Standard Deviation 17.8 |
Comparison: We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.p-value: <0.001Friedman
Primary
Metabolic Syndrome Parameter Body Weight
Iterative measurement of body weight. Mean at time points.
Time frame: Baseline, 1 Month, 4 Months
Population: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Body Weight | Baseline | 74.27 kg (kilogram) | Standard Deviation 43 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Body Weight | 1 Month | 75.06 kg (kilogram) | Standard Deviation 46 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Body Weight | 4 Months | 76.18 kg (kilogram) | Standard Deviation 46 |
Comparison: We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.p-value: <0.001Friedman
Primary
Metabolic Syndrome Parameter Fasting Blood Sugar
Iterative measurement of fasting blood sugar. Mean at time points.
Time frame: Baseline, 1 Month, 4 Months
Population: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Fasting Blood Sugar | Baseline | 80.82 mg/dl (miligrams per deciliter) | Standard Deviation 24.17 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Fasting Blood Sugar | 1 Month | 77.64 mg/dl (miligrams per deciliter) | Standard Deviation 17.74 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Fasting Blood Sugar | 4 Months | 76.79 mg/dl (miligrams per deciliter) | Standard Deviation 19.85 |
Comparison: Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).p-value: 0.544Friedman
Primary
Metabolic Syndrome Parameter High Density Lipoprotein (HDL)
Iterative measurement of HDL. Mean at time points
Time frame: Baseline, 1 Month, 4 Months
Population: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter High Density Lipoprotein (HDL) | Baseline | 35.11 mg/dl | Standard Deviation 13.24 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter High Density Lipoprotein (HDL) | 1 Month | 36.99 mg/dl | Standard Deviation 16.08 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter High Density Lipoprotein (HDL) | 4 Months | 35.51 mg/dl | Standard Deviation 12 |
Comparison: Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).p-value: 0.176Friedman
Primary
Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)
Iterative measurement of LDL. Mean at time points
Time frame: Baseline, 1 Month, 4 Months
Population: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Low Density Lipoprotein (LDL) | Baseline | 118.71 mg/dl | Standard Deviation 38.96 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Low Density Lipoprotein (LDL) | 1 Month | 122.56 mg/dl | Standard Deviation 43.23 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Low Density Lipoprotein (LDL) | 4 Months | 122.86 mg/dl | Standard Deviation 39.21 |
Comparison: Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).p-value: 0.362Friedman
Primary
Metabolic Syndrome Parameter Total Cholesterol
Iterative measurement of total cholesterol. Mean at time points.
Time frame: Baseline, 1 Month, 4 Months
Population: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Total Cholesterol | Baseline | 178.48 mg/dl | Standard Deviation 47.83 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Total Cholesterol | 1 Month | 181.81 mg/dl | Standard Deviation 52.81 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Total Cholesterol | 4 Months | 179.67 mg/dl | Standard Deviation 45.27 |
Comparison: Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).p-value: 0.245Friedman
Primary
Metabolic Syndrome Parameter Triglycerides
Iterative measurement of triglycerides. Mean at time points
Time frame: Baseline, 1 Month, 4 Months
Population: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Triglycerides | Baseline | 115.11 mg/dl | Standard Deviation 78.88 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Triglycerides | 1 Month | 116.46 mg/dl | Standard Deviation 72.45 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Triglycerides | 4 Months | 127.63 mg/dl | Standard Deviation 83.45 |
Comparison: Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).p-value: <0.001Friedman
Primary
Metabolic Syndrome Parameter Waist Circumference
Iterative measurement of waist circumference. Mean at timepoints.
Time frame: Baseline, 1 Month, 4 Months
Population: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Waist Circumference | Baseline | 91.92 cm (centimeter) | Standard Deviation 14.91 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Waist Circumference | 1 Month | 92.07 cm (centimeter) | Standard Deviation 13.54 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Waist Circumference | 4 Months | 92.80 cm (centimeter) | Standard Deviation 12.99 |
Comparison: Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).p-value: <0.001Friedman
Secondary
Metabolic Syndrome Parameter BMI by Treatment Group
Iterative measurement of BMI. Mean at time points.
Time frame: Baseline, 1 Month, 4 Months
Population: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter BMI by Treatment Group | 4 Months | 26.19 kg/m*m | Standard Deviation 17.9 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter BMI by Treatment Group | 1 Month | 26.10 kg/m*m | Standard Deviation 17.28 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter BMI by Treatment Group | Baseline | 26.12 kg/m*m | Standard Deviation 18.21 |
| Risperidone | Metabolic Syndrome Parameter BMI by Treatment Group | 1 Month | 26.52 kg/m*m | Standard Deviation 18.65 |
| Risperidone | Metabolic Syndrome Parameter BMI by Treatment Group | Baseline | 26.17 kg/m*m | Standard Deviation 17.93 |
| Risperidone | Metabolic Syndrome Parameter BMI by Treatment Group | 4 Months | 27.23 kg/m*m | Standard Deviation 20.08 |
| Quetiapine | Metabolic Syndrome Parameter BMI by Treatment Group | 4 Months | 28.41 kg/m*m | Standard Deviation 21.77 |
| Quetiapine | Metabolic Syndrome Parameter BMI by Treatment Group | Baseline | 26.94 kg/m*m | Standard Deviation 19.82 |
| Quetiapine | Metabolic Syndrome Parameter BMI by Treatment Group | 1 Month | 27.70 kg/m*m | Standard Deviation 20.15 |
| Olanzipine | Metabolic Syndrome Parameter BMI by Treatment Group | 1 Month | 24.81 kg/m*m | Standard Deviation 19.05 |
| Olanzipine | Metabolic Syndrome Parameter BMI by Treatment Group | Baseline | 24.06 kg/m*m | Standard Deviation 18.04 |
| Olanzipine | Metabolic Syndrome Parameter BMI by Treatment Group | 4 Months | 25.39 kg/m*m | Standard Deviation 20.34 |
| Aripiprazole | Metabolic Syndrome Parameter BMI by Treatment Group | 1 Month | 29.39 kg/m*m | Standard Deviation 16.33 |
| Aripiprazole | Metabolic Syndrome Parameter BMI by Treatment Group | Baseline | 29.76 kg/m*m | Standard Deviation 16.78 |
| Aripiprazole | Metabolic Syndrome Parameter BMI by Treatment Group | 4 Months | 28.75 kg/m*m | Standard Deviation 18.34 |
| Amisulpride | Metabolic Syndrome Parameter BMI by Treatment Group | Baseline | 24.92 kg/m*m | Standard Deviation 18.25 |
| Amisulpride | Metabolic Syndrome Parameter BMI by Treatment Group | 4 Months | 25.88 kg/m*m | Standard Deviation 20.31 |
| Amisulpride | Metabolic Syndrome Parameter BMI by Treatment Group | 1 Month | 25.12 kg/m*m | Standard Deviation 19.43 |
| Other | Metabolic Syndrome Parameter BMI by Treatment Group | 4 Months | 27.76 kg/m*m | Standard Deviation 17.79 |
| Other | Metabolic Syndrome Parameter BMI by Treatment Group | 1 Month | 26.93 kg/m*m | Standard Deviation 16.37 |
| Other | Metabolic Syndrome Parameter BMI by Treatment Group | Baseline | 26.41 kg/m*m | Standard Deviation 16.72 |
Comparison: Friedman's test was used to assess trends over time.p-value: 0.49Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: <0.001Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.006Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: <0.001Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.003Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: <0.001Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.05Friedman
p-value: 0.0012Wilcoxon (Mann-Whitney)
p-value: 0.0078Wilcoxon (Mann-Whitney)
p-value: 0.0001Wilcoxon (Mann-Whitney)
p-value: 0.0133Wilcoxon (Mann-Whitney)
p-value: 0.0142Wilcoxon (Mann-Whitney)
p-value: 0.0265Wilcoxon (Mann-Whitney)
p-value: 0.1613Wilcoxon (Mann-Whitney)
p-value: 0.2644Wilcoxon (Mann-Whitney)
p-value: 0.000005Wilcoxon (Mann-Whitney)
p-value: 0.7385Wilcoxon (Mann-Whitney)
p-value: 1Wilcoxon (Mann-Whitney)
p-value: 0.6813Wilcoxon (Mann-Whitney)
p-value: 0.0024Wilcoxon (Mann-Whitney)
p-value: 0.2237Wilcoxon (Mann-Whitney)
p-value: 0.5774Wilcoxon (Mann-Whitney)
p-value: 0.000001Wilcoxon (Mann-Whitney)
p-value: 0.2502Wilcoxon (Mann-Whitney)
p-value: 0.5224Wilcoxon (Mann-Whitney)
p-value: 0.0001Wilcoxon (Mann-Whitney)
p-value: 0.0002Wilcoxon (Mann-Whitney)
p-value: 0.8166Wilcoxon (Mann-Whitney)
Secondary
Metabolic Syndrome Parameter Triglycerides by Treatment Group
Iterative measurement of triglycerides. Mean at time points.
Time frame: Baseline, 1 Month, 4 Months
Population: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 4 Months | 94.04 mg/dl | Standard Deviation 45.98 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 1 Month | 92.25 mg/dl | Standard Deviation 55.81 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Triglycerides by Treatment Group | Baseline | 104.89 mg/dl | Standard Deviation 85.13 |
| Risperidone | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 1 Month | 121.00 mg/dl | Standard Deviation 78.34 |
| Risperidone | Metabolic Syndrome Parameter Triglycerides by Treatment Group | Baseline | 129.66 mg/dl | Standard Deviation 90.13 |
| Risperidone | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 4 Months | 148.14 mg/dl | Standard Deviation 88.69 |
| Quetiapine | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 4 Months | 119.33 mg/dl | Standard Deviation 55.21 |
| Quetiapine | Metabolic Syndrome Parameter Triglycerides by Treatment Group | Baseline | 117.92 mg/dl | Standard Deviation 80.54 |
| Quetiapine | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 1 Month | 141.50 mg/dl | Standard Deviation 78.34 |
| Olanzipine | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 1 Month | 97.48 mg/dl | Standard Deviation 49.76 |
| Olanzipine | Metabolic Syndrome Parameter Triglycerides by Treatment Group | Baseline | 86.24 mg/dl | Standard Deviation 40 |
| Olanzipine | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 4 Months | 110.97 mg/dl | Standard Deviation 52.32 |
| Aripiprazole | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 1 Month | 111.78 mg/dl | Standard Deviation 82.98 |
| Aripiprazole | Metabolic Syndrome Parameter Triglycerides by Treatment Group | Baseline | 113.79 mg/dl | Standard Deviation 88.12 |
| Aripiprazole | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 4 Months | 127.07 mg/dl | Standard Deviation 80.83 |
| Amisulpride | Metabolic Syndrome Parameter Triglycerides by Treatment Group | Baseline | 142.75 mg/dl | Standard Deviation 83.42 |
| Amisulpride | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 4 Months | 161.85 mg/dl | Standard Deviation 143.26 |
| Amisulpride | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 1 Month | 133.90 mg/dl | Standard Deviation 67.17 |
| Other | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 4 Months | 148.00 mg/dl | Standard Deviation 81.76 |
| Other | Metabolic Syndrome Parameter Triglycerides by Treatment Group | 1 Month | 157.38 mg/dl | Standard Deviation 90.16 |
| Other | Metabolic Syndrome Parameter Triglycerides by Treatment Group | Baseline | 131.88 mg/dl | Standard Deviation 74.23 |
Comparison: Friedman's test was used to assess trends over time.p-value: 0.077Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.039Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.978Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: <0.001Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.593Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.987Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.174Friedman
Secondary
Metabolic Syndrome Parameter Waist Circumference by Treatment Group
Iterative measurement of waist circumference. Mean at time points.
Time frame: Baseline, 1 Month, 4 Months
Population: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 4 Months | 90.70 cm (centimeter) | Standard Deviation 14.84 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 1 Month | 90.42 cm (centimeter) | Standard Deviation 15.3 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | Baseline | 91.18 cm (centimeter) | Standard Deviation 14.62 |
| Risperidone | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 1 Month | 93.36 cm (centimeter) | Standard Deviation 14.5 |
| Risperidone | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | Baseline | 91.55 cm (centimeter) | Standard Deviation 13.58 |
| Risperidone | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 4 Months | 93.52 cm (centimeter) | Standard Deviation 13.64 |
| Quetiapine | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 4 Months | 97.18 cm (centimeter) | Standard Deviation 14.46 |
| Quetiapine | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | Baseline | 93.75 cm (centimeter) | Standard Deviation 13.37 |
| Quetiapine | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 1 Month | 97.28 cm (centimeter) | Standard Deviation 14.6 |
| Olanzipine | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 1 Month | 87.57 cm (centimeter) | Standard Deviation 9.47 |
| Olanzipine | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | Baseline | 89.04 cm (centimeter) | Standard Deviation 18.95 |
| Olanzipine | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 4 Months | 89.69 cm (centimeter) | Standard Deviation 8.82 |
| Aripiprazole | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 1 Month | 96.27 cm (centimeter) | Standard Deviation 15.72 |
| Aripiprazole | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | Baseline | 96.64 cm (centimeter) | Standard Deviation 15.41 |
| Aripiprazole | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 4 Months | 94.92 cm (centimeter) | Standard Deviation 15.17 |
| Amisulpride | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | Baseline | 88.80 cm (centimeter) | Standard Deviation 12.38 |
| Amisulpride | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 4 Months | 90.34 cm (centimeter) | Standard Deviation 11.82 |
| Amisulpride | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 1 Month | 88.53 cm (centimeter) | Standard Deviation 10.83 |
| Other | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 4 Months | 97.44 cm (centimeter) | Standard Deviation 10.35 |
| Other | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | 1 Month | 94.89 cm (centimeter) | Standard Deviation 11.08 |
| Other | Metabolic Syndrome Parameter Waist Circumference by Treatment Group | Baseline | 94.06 cm (centimeter) | Standard Deviation 11.53 |
Comparison: Friedman's test was used to assess trends over time.p-value: 0.197Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.01Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.012Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: <0.001Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.282Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.04Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.004Friedman
p-value: 0.0193Wilcoxon (Mann-Whitney)
p-value: 0.0065Wilcoxon (Mann-Whitney)
p-value: 0.0002Wilcoxon (Mann-Whitney)
p-value: 0.3172Wilcoxon (Mann-Whitney)
p-value: 0.0116Wilcoxon (Mann-Whitney)
p-value: 0.0016Wilcoxon (Mann-Whitney)
p-value: 0.26Wilcoxon (Mann-Whitney)
p-value: 0.2309Wilcoxon (Mann-Whitney)
p-value: 0.0063Wilcoxon (Mann-Whitney)
p-value: 0.8158Wilcoxon (Mann-Whitney)
p-value: 0.3968Wilcoxon (Mann-Whitney)
p-value: 0.7193Wilcoxon (Mann-Whitney)
p-value: 0.0127Wilcoxon (Mann-Whitney)
p-value: 0.2351Wilcoxon (Mann-Whitney)
p-value: 0.5672Wilcoxon (Mann-Whitney)
p-value: 0.00009Wilcoxon (Mann-Whitney)
p-value: 0.1774Wilcoxon (Mann-Whitney)
p-value: 0.6082Wilcoxon (Mann-Whitney)
p-value: 0.0079Wilcoxon (Mann-Whitney)
p-value: 0.0014Wilcoxon (Mann-Whitney)
p-value: 0.5587Wilcoxon (Mann-Whitney)
Secondary
Metabolic Syndrome Parameter Weight by Treatment Group
Iterative measurement of weight. Mean at time points.
Time frame: Baseline, 1 Month, 4 Months
Population: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Weight by Treatment Group | 4 Months | 73.43 kg | Standard Deviation 14.44 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Weight by Treatment Group | 1 Month | 73.04 kg | Standard Deviation 14.11 |
| Atypical Antipsychotic Treatment | Metabolic Syndrome Parameter Weight by Treatment Group | Baseline | 73.11 kg | Standard Deviation 14.1 |
| Risperidone | Metabolic Syndrome Parameter Weight by Treatment Group | 1 Month | 73.46 kg | Standard Deviation 13.14 |
| Risperidone | Metabolic Syndrome Parameter Weight by Treatment Group | Baseline | 72.39 kg | Standard Deviation 12.5 |
| Risperidone | Metabolic Syndrome Parameter Weight by Treatment Group | 4 Months | 75.47 kg | Standard Deviation 13.37 |
| Quetiapine | Metabolic Syndrome Parameter Weight by Treatment Group | 4 Months | 80.43 kg | Standard Deviation 17.52 |
| Quetiapine | Metabolic Syndrome Parameter Weight by Treatment Group | Baseline | 76.22 kg | Standard Deviation 18.01 |
| Quetiapine | Metabolic Syndrome Parameter Weight by Treatment Group | 1 Month | 78.41 kg | Standard Deviation 18.09 |
| Olanzipine | Metabolic Syndrome Parameter Weight by Treatment Group | 1 Month | 71.97 kg | Standard Deviation 10.23 |
| Olanzipine | Metabolic Syndrome Parameter Weight by Treatment Group | Baseline | 69.82 kg | Standard Deviation 10.72 |
| Olanzipine | Metabolic Syndrome Parameter Weight by Treatment Group | 4 Months | 73.68 kg | Standard Deviation 9.87 |
| Aripiprazole | Metabolic Syndrome Parameter Weight by Treatment Group | 1 Month | 83.23 kg | Standard Deviation 19.81 |
| Aripiprazole | Metabolic Syndrome Parameter Weight by Treatment Group | Baseline | 84.26 kg | Standard Deviation 20.37 |
| Aripiprazole | Metabolic Syndrome Parameter Weight by Treatment Group | 4 Months | 81.55 kg | Standard Deviation 17.24 |
| Amisulpride | Metabolic Syndrome Parameter Weight by Treatment Group | Baseline | 70.68 kg | Standard Deviation 13.49 |
| Amisulpride | Metabolic Syndrome Parameter Weight by Treatment Group | 4 Months | 73.45 kg | Standard Deviation 13.64 |
| Amisulpride | Metabolic Syndrome Parameter Weight by Treatment Group | 1 Month | 71.02 kg | Standard Deviation 12.96 |
| Other | Metabolic Syndrome Parameter Weight by Treatment Group | 4 Months | 78.54 kg | Standard Deviation 14.96 |
| Other | Metabolic Syndrome Parameter Weight by Treatment Group | 1 Month | 76.47 kg | Standard Deviation 15.01 |
| Other | Metabolic Syndrome Parameter Weight by Treatment Group | Baseline | 74.77 kg | Standard Deviation 15.17 |
p-value: 0.5153Wilcoxon (Mann-Whitney)
p-value: 0.0003Wilcoxon (Mann-Whitney)
p-value: 0.0005Wilcoxon (Mann-Whitney)
Comparison: Friedman's test was used to assess trends over time.p-value: 0.524Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: <0.001Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.005Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: <0.001Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.009Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: <0.001Friedman
Comparison: Friedman's test was used to assess trends over time.p-value: 0.047Friedman
p-value: 0.0007Wilcoxon (Mann-Whitney)
p-value: 0.0057Wilcoxon (Mann-Whitney)
p-value: 0.00009Wilcoxon (Mann-Whitney)
p-value: 0.0201Wilcoxon (Mann-Whitney)
p-value: 0.0095Wilcoxon (Mann-Whitney)
p-value: 0.0386Wilcoxon (Mann-Whitney)
p-value: 0.1976Wilcoxon (Mann-Whitney)
p-value: 0.2383Wilcoxon (Mann-Whitney)
p-value: 0.00002Wilcoxon (Mann-Whitney)
p-value: 0.8297Wilcoxon (Mann-Whitney)
p-value: 0.9081Wilcoxon (Mann-Whitney)
p-value: 0.7386Wilcoxon (Mann-Whitney)
p-value: 0.0024Wilcoxon (Mann-Whitney)
p-value: 0.2587Wilcoxon (Mann-Whitney)
p-value: 0.6263Wilcoxon (Mann-Whitney)
p-value: 0.000001Wilcoxon (Mann-Whitney)
p-value: 0.2589Wilcoxon (Mann-Whitney)
p-value: 0.8952Wilcoxon (Mann-Whitney)