Trial Outcomes & Findings for An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics (NCT NCT00448630)
NCT ID: NCT00448630
Last Updated: 2022-05-03
Results Overview
Iterative mean Body Mass Index at time points.
Recruitment status
COMPLETED
Target enrollment
328 participants
Primary outcome timeframe
Baseline, 1 Month, 4 Months
Results posted on
2022-05-03
Participant Flow
Subjects diagnosed with schizophrenia who have been using or recommended to use atypical antipsychotic drugs.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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328
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Overall Study
COMPLETED
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301
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Overall Study
NOT COMPLETED
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27
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics
Baseline characteristics by cohort
| Measure |
Atypical Antipsychotic Treatment
n=328 Participants
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.
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|---|---|
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Age, Continuous
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37.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
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Sex: Female, Male
Female
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206 Participants
n=5 Participants
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Sex: Female, Male
Male
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122 Participants
n=5 Participants
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Region of Enrollment
Turkey
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328 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, 1 Month, 4 MonthsPopulation: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
Iterative mean Body Mass Index at time points.
Outcome measures
| Measure |
Atypical Antipsychotic Treatment
n=163 Participants
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.
|
Risperidone
risperidone as prescribed by subject's physician
|
Quetiapine
quetiapine as prescribed by subject's physician
|
Olanzipine
olanzipine as prescribed by subject's physician
|
Aripiprazole
aripiprazole as prescribed by subject's physician
|
Amisulpride
amisulpride as prescribed by subject's physician
|
Other
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
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|---|---|---|---|---|---|---|---|
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Metabolic Syndrome Parameter Body Mass Index (BMI)
Baseline
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26.3 kg/m*m (kilograms per meter squared)
Standard Deviation 16.7
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Body Mass Index (BMI)
1 Month
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26.6 kg/m*m (kilograms per meter squared)
Standard Deviation 16.3
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Body Mass Index (BMI)
4 Months
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26.9 kg/m*m (kilograms per meter squared)
Standard Deviation 17.8
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Baseline, 1 Month, 4 MonthsPopulation: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
Iterative measurement of body weight. Mean at time points.
Outcome measures
| Measure |
Atypical Antipsychotic Treatment
n=173 Participants
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.
|
Risperidone
risperidone as prescribed by subject's physician
|
Quetiapine
quetiapine as prescribed by subject's physician
|
Olanzipine
olanzipine as prescribed by subject's physician
|
Aripiprazole
aripiprazole as prescribed by subject's physician
|
Amisulpride
amisulpride as prescribed by subject's physician
|
Other
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
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|---|---|---|---|---|---|---|---|
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Metabolic Syndrome Parameter Body Weight
Baseline
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74.27 kg (kilogram)
Standard Deviation 43
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Body Weight
1 Month
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75.06 kg (kilogram)
Standard Deviation 46
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Body Weight
4 Months
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76.18 kg (kilogram)
Standard Deviation 46
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Baseline, 1 Month, 4 MonthsPopulation: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
Iterative measurement of waist circumference. Mean at timepoints.
Outcome measures
| Measure |
Atypical Antipsychotic Treatment
n=173 Participants
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.
|
Risperidone
risperidone as prescribed by subject's physician
|
Quetiapine
quetiapine as prescribed by subject's physician
|
Olanzipine
olanzipine as prescribed by subject's physician
|
Aripiprazole
aripiprazole as prescribed by subject's physician
|
Amisulpride
amisulpride as prescribed by subject's physician
|
Other
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
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|---|---|---|---|---|---|---|---|
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Metabolic Syndrome Parameter Waist Circumference
Baseline
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91.92 cm (centimeter)
Standard Deviation 14.91
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Waist Circumference
1 Month
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92.07 cm (centimeter)
Standard Deviation 13.54
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Waist Circumference
4 Months
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92.80 cm (centimeter)
Standard Deviation 12.99
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Baseline, 1 Month, 4 MonthsPopulation: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
Iterative measurement of fasting blood sugar. Mean at time points.
Outcome measures
| Measure |
Atypical Antipsychotic Treatment
n=168 Participants
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.
|
Risperidone
risperidone as prescribed by subject's physician
|
Quetiapine
quetiapine as prescribed by subject's physician
|
Olanzipine
olanzipine as prescribed by subject's physician
|
Aripiprazole
aripiprazole as prescribed by subject's physician
|
Amisulpride
amisulpride as prescribed by subject's physician
|
Other
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
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|---|---|---|---|---|---|---|---|
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Metabolic Syndrome Parameter Fasting Blood Sugar
Baseline
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80.82 mg/dl (miligrams per deciliter)
Standard Deviation 24.17
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Fasting Blood Sugar
1 Month
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77.64 mg/dl (miligrams per deciliter)
Standard Deviation 17.74
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Fasting Blood Sugar
4 Months
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76.79 mg/dl (miligrams per deciliter)
Standard Deviation 19.85
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Baseline, 1 Month, 4 MonthsPopulation: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
Iterative measurement of total cholesterol. Mean at time points.
Outcome measures
| Measure |
Atypical Antipsychotic Treatment
n=166 Participants
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.
|
Risperidone
risperidone as prescribed by subject's physician
|
Quetiapine
quetiapine as prescribed by subject's physician
|
Olanzipine
olanzipine as prescribed by subject's physician
|
Aripiprazole
aripiprazole as prescribed by subject's physician
|
Amisulpride
amisulpride as prescribed by subject's physician
|
Other
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
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|---|---|---|---|---|---|---|---|
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Metabolic Syndrome Parameter Total Cholesterol
Baseline
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178.48 mg/dl
Standard Deviation 47.83
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Total Cholesterol
1 Month
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181.81 mg/dl
Standard Deviation 52.81
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Total Cholesterol
4 Months
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179.67 mg/dl
Standard Deviation 45.27
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Baseline, 1 Month, 4 MonthsPopulation: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
Iterative measurement of LDL. Mean at time points
Outcome measures
| Measure |
Atypical Antipsychotic Treatment
n=143 Participants
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.
|
Risperidone
risperidone as prescribed by subject's physician
|
Quetiapine
quetiapine as prescribed by subject's physician
|
Olanzipine
olanzipine as prescribed by subject's physician
|
Aripiprazole
aripiprazole as prescribed by subject's physician
|
Amisulpride
amisulpride as prescribed by subject's physician
|
Other
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
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|---|---|---|---|---|---|---|---|
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Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)
Baseline
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118.71 mg/dl
Standard Deviation 38.96
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)
1 Month
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122.56 mg/dl
Standard Deviation 43.23
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)
4 Months
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122.86 mg/dl
Standard Deviation 39.21
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Baseline, 1 Month, 4 MonthsPopulation: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
Iterative measurement of HDL. Mean at time points
Outcome measures
| Measure |
Atypical Antipsychotic Treatment
n=165 Participants
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.
|
Risperidone
risperidone as prescribed by subject's physician
|
Quetiapine
quetiapine as prescribed by subject's physician
|
Olanzipine
olanzipine as prescribed by subject's physician
|
Aripiprazole
aripiprazole as prescribed by subject's physician
|
Amisulpride
amisulpride as prescribed by subject's physician
|
Other
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
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|---|---|---|---|---|---|---|---|
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Metabolic Syndrome Parameter High Density Lipoprotein (HDL)
Baseline
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35.11 mg/dl
Standard Deviation 13.24
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter High Density Lipoprotein (HDL)
1 Month
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36.99 mg/dl
Standard Deviation 16.08
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter High Density Lipoprotein (HDL)
4 Months
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35.51 mg/dl
Standard Deviation 12.00
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Baseline, 1 Month, 4 MonthsPopulation: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
Iterative measurement of triglycerides. Mean at time points
Outcome measures
| Measure |
Atypical Antipsychotic Treatment
n=166 Participants
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.
|
Risperidone
risperidone as prescribed by subject's physician
|
Quetiapine
quetiapine as prescribed by subject's physician
|
Olanzipine
olanzipine as prescribed by subject's physician
|
Aripiprazole
aripiprazole as prescribed by subject's physician
|
Amisulpride
amisulpride as prescribed by subject's physician
|
Other
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
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|---|---|---|---|---|---|---|---|
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Metabolic Syndrome Parameter Triglycerides
Baseline
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115.11 mg/dl
Standard Deviation 78.88
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Triglycerides
1 Month
|
116.46 mg/dl
Standard Deviation 72.45
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—
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—
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—
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—
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—
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—
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Metabolic Syndrome Parameter Triglycerides
4 Months
|
127.63 mg/dl
Standard Deviation 83.45
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Baseline, 1 Month, 4 MonthsPopulation: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
Iterative measurement of BMI. Mean at time points.
Outcome measures
| Measure |
Atypical Antipsychotic Treatment
n=25 Participants
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.
|
Risperidone
n=31 Participants
risperidone as prescribed by subject's physician
|
Quetiapine
n=12 Participants
quetiapine as prescribed by subject's physician
|
Olanzipine
n=33 Participants
olanzipine as prescribed by subject's physician
|
Aripiprazole
n=27 Participants
aripiprazole as prescribed by subject's physician
|
Amisulpride
n=19 Participants
amisulpride as prescribed by subject's physician
|
Other
n=16 Participants
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
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|---|---|---|---|---|---|---|---|
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Metabolic Syndrome Parameter BMI by Treatment Group
Baseline
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26.12 kg/m*m
Standard Deviation 18.21
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26.17 kg/m*m
Standard Deviation 17.93
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26.94 kg/m*m
Standard Deviation 19.82
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24.06 kg/m*m
Standard Deviation 18.04
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29.76 kg/m*m
Standard Deviation 16.78
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24.92 kg/m*m
Standard Deviation 18.25
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26.41 kg/m*m
Standard Deviation 16.72
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Metabolic Syndrome Parameter BMI by Treatment Group
1 Month
|
26.10 kg/m*m
Standard Deviation 17.28
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26.52 kg/m*m
Standard Deviation 18.65
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27.70 kg/m*m
Standard Deviation 20.15
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24.81 kg/m*m
Standard Deviation 19.05
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29.39 kg/m*m
Standard Deviation 16.33
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25.12 kg/m*m
Standard Deviation 19.43
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26.93 kg/m*m
Standard Deviation 16.37
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Metabolic Syndrome Parameter BMI by Treatment Group
4 Months
|
26.19 kg/m*m
Standard Deviation 17.90
|
27.23 kg/m*m
Standard Deviation 20.08
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28.41 kg/m*m
Standard Deviation 21.77
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25.39 kg/m*m
Standard Deviation 20.34
|
28.75 kg/m*m
Standard Deviation 18.34
|
25.88 kg/m*m
Standard Deviation 20.31
|
27.76 kg/m*m
Standard Deviation 17.79
|
SECONDARY outcome
Timeframe: Baseline, 1 Month, 4 MonthsPopulation: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
Iterative measurement of weight. Mean at time points.
Outcome measures
| Measure |
Atypical Antipsychotic Treatment
n=31 Participants
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.
|
Risperidone
n=31 Participants
risperidone as prescribed by subject's physician
|
Quetiapine
n=12 Participants
quetiapine as prescribed by subject's physician
|
Olanzipine
n=33 Participants
olanzipine as prescribed by subject's physician
|
Aripiprazole
n=28 Participants
aripiprazole as prescribed by subject's physician
|
Amisulpride
n=20 Participants
amisulpride as prescribed by subject's physician
|
Other
n=18 Participants
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
|
|---|---|---|---|---|---|---|---|
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Metabolic Syndrome Parameter Weight by Treatment Group
Baseline
|
73.11 kg
Standard Deviation 14.10
|
72.39 kg
Standard Deviation 12.50
|
76.22 kg
Standard Deviation 18.01
|
69.82 kg
Standard Deviation 10.72
|
84.26 kg
Standard Deviation 20.37
|
70.68 kg
Standard Deviation 13.49
|
74.77 kg
Standard Deviation 15.17
|
|
Metabolic Syndrome Parameter Weight by Treatment Group
1 Month
|
73.04 kg
Standard Deviation 14.11
|
73.46 kg
Standard Deviation 13.14
|
78.41 kg
Standard Deviation 18.09
|
71.97 kg
Standard Deviation 10.23
|
83.23 kg
Standard Deviation 19.81
|
71.02 kg
Standard Deviation 12.96
|
76.47 kg
Standard Deviation 15.01
|
|
Metabolic Syndrome Parameter Weight by Treatment Group
4 Months
|
73.43 kg
Standard Deviation 14.44
|
75.47 kg
Standard Deviation 13.37
|
80.43 kg
Standard Deviation 17.52
|
73.68 kg
Standard Deviation 9.87
|
81.55 kg
Standard Deviation 17.24
|
73.45 kg
Standard Deviation 13.64
|
78.54 kg
Standard Deviation 14.96
|
SECONDARY outcome
Timeframe: Baseline, 1 Month, 4 MonthsPopulation: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
Iterative measurement of waist circumference. Mean at time points.
Outcome measures
| Measure |
Atypical Antipsychotic Treatment
n=31 Participants
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.
|
Risperidone
n=31 Participants
risperidone as prescribed by subject's physician
|
Quetiapine
n=12 Participants
quetiapine as prescribed by subject's physician
|
Olanzipine
n=33 Participants
olanzipine as prescribed by subject's physician
|
Aripiprazole
n=28 Participants
aripiprazole as prescribed by subject's physician
|
Amisulpride
n=20 Participants
amisulpride as prescribed by subject's physician
|
Other
n=18 Participants
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
|
|---|---|---|---|---|---|---|---|
|
Metabolic Syndrome Parameter Waist Circumference by Treatment Group
4 Months
|
90.70 cm (centimeter)
Standard Deviation 14.84
|
93.52 cm (centimeter)
Standard Deviation 13.64
|
97.18 cm (centimeter)
Standard Deviation 14.46
|
89.69 cm (centimeter)
Standard Deviation 8.82
|
94.92 cm (centimeter)
Standard Deviation 15.17
|
90.34 cm (centimeter)
Standard Deviation 11.82
|
97.44 cm (centimeter)
Standard Deviation 10.35
|
|
Metabolic Syndrome Parameter Waist Circumference by Treatment Group
Baseline
|
91.18 cm (centimeter)
Standard Deviation 14.62
|
91.55 cm (centimeter)
Standard Deviation 13.58
|
93.75 cm (centimeter)
Standard Deviation 13.37
|
89.04 cm (centimeter)
Standard Deviation 18.95
|
96.64 cm (centimeter)
Standard Deviation 15.41
|
88.80 cm (centimeter)
Standard Deviation 12.38
|
94.06 cm (centimeter)
Standard Deviation 11.53
|
|
Metabolic Syndrome Parameter Waist Circumference by Treatment Group
1 Month
|
90.42 cm (centimeter)
Standard Deviation 15.30
|
93.36 cm (centimeter)
Standard Deviation 14.50
|
97.28 cm (centimeter)
Standard Deviation 14.60
|
87.57 cm (centimeter)
Standard Deviation 9.47
|
96.27 cm (centimeter)
Standard Deviation 15.72
|
88.53 cm (centimeter)
Standard Deviation 10.83
|
94.89 cm (centimeter)
Standard Deviation 11.08
|
SECONDARY outcome
Timeframe: Baseline, 1 Month, 4 MonthsPopulation: Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.
Iterative measurement of triglycerides. Mean at time points.
Outcome measures
| Measure |
Atypical Antipsychotic Treatment
n=28 Participants
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.
|
Risperidone
n=29 Participants
risperidone as prescribed by subject's physician
|
Quetiapine
n=12 Participants
quetiapine as prescribed by subject's physician
|
Olanzipine
n=33 Participants
olanzipine as prescribed by subject's physician
|
Aripiprazole
n=28 Participants
aripiprazole as prescribed by subject's physician
|
Amisulpride
n=20 Participants
amisulpride as prescribed by subject's physician
|
Other
n=16 Participants
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
|
|---|---|---|---|---|---|---|---|
|
Metabolic Syndrome Parameter Triglycerides by Treatment Group
Baseline
|
104.89 mg/dl
Standard Deviation 85.13
|
129.66 mg/dl
Standard Deviation 90.13
|
117.92 mg/dl
Standard Deviation 80.54
|
86.24 mg/dl
Standard Deviation 40.00
|
113.79 mg/dl
Standard Deviation 88.12
|
142.75 mg/dl
Standard Deviation 83.42
|
131.88 mg/dl
Standard Deviation 74.23
|
|
Metabolic Syndrome Parameter Triglycerides by Treatment Group
1 Month
|
92.25 mg/dl
Standard Deviation 55.81
|
121.00 mg/dl
Standard Deviation 78.34
|
141.50 mg/dl
Standard Deviation 78.34
|
97.48 mg/dl
Standard Deviation 49.76
|
111.78 mg/dl
Standard Deviation 82.98
|
133.90 mg/dl
Standard Deviation 67.17
|
157.38 mg/dl
Standard Deviation 90.16
|
|
Metabolic Syndrome Parameter Triglycerides by Treatment Group
4 Months
|
94.04 mg/dl
Standard Deviation 45.98
|
148.14 mg/dl
Standard Deviation 88.69
|
119.33 mg/dl
Standard Deviation 55.21
|
110.97 mg/dl
Standard Deviation 52.32
|
127.07 mg/dl
Standard Deviation 80.83
|
161.85 mg/dl
Standard Deviation 143.26
|
148.00 mg/dl
Standard Deviation 81.76
|
Adverse Events
Ziprasidone
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Risperidone
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Quetiapine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Olanzipine
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Aripiprazole
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Amisulpride
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Other
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ziprasidone
n=57 participants at risk
ziprasidone as prescribed by subject's physician
|
Risperidone
n=64 participants at risk
risperidone as prescribed by subject's physician
|
Quetiapine
n=23 participants at risk
quetiapine as prescribed by subject's physician
|
Olanzipine
n=60 participants at risk
olanzipine as prescribed by subject's physician
|
Aripiprazole
n=50 participants at risk
aripiprazole as prescribed by subject's physician
|
Amisulpride
n=41 participants at risk
amisulpride as prescribed by subject's physician
|
Other
n=33 participants at risk
other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Menstrual irregularities
|
0.00%
0/57
|
0.00%
0/64
|
0.00%
0/23
|
1.7%
1/60
|
0.00%
0/50
|
0.00%
0/41
|
0.00%
0/33
|
|
General disorders
Mouth dryness
|
0.00%
0/57
|
0.00%
0/64
|
0.00%
0/23
|
0.00%
0/60
|
0.00%
0/50
|
0.00%
0/41
|
3.0%
1/33
|
|
General disorders
Akathisia
|
0.00%
0/57
|
1.6%
1/64
|
0.00%
0/23
|
0.00%
0/60
|
0.00%
0/50
|
0.00%
0/41
|
15.2%
5/33
|
|
General disorders
Akathisia + sedation
|
0.00%
0/57
|
1.6%
1/64
|
0.00%
0/23
|
0.00%
0/60
|
0.00%
0/50
|
0.00%
0/41
|
0.00%
0/33
|
|
General disorders
Allergy + Sedation
|
0.00%
0/57
|
1.6%
1/64
|
0.00%
0/23
|
1.7%
1/60
|
0.00%
0/50
|
0.00%
0/41
|
0.00%
0/33
|
|
General disorders
Giddiness
|
1.8%
1/57
|
0.00%
0/64
|
0.00%
0/23
|
0.00%
0/60
|
0.00%
0/50
|
0.00%
0/41
|
0.00%
0/33
|
|
General disorders
Nausea
|
0.00%
0/57
|
0.00%
0/64
|
0.00%
0/23
|
0.00%
0/60
|
0.00%
0/50
|
2.4%
1/41
|
0.00%
0/33
|
|
General disorders
Dyspahlgia
|
0.00%
0/57
|
0.00%
0/64
|
0.00%
0/23
|
0.00%
0/60
|
0.00%
0/50
|
0.00%
0/41
|
3.0%
1/33
|
|
General disorders
Dystasia
|
0.00%
0/57
|
0.00%
0/64
|
0.00%
0/23
|
0.00%
0/60
|
2.0%
1/50
|
0.00%
0/41
|
0.00%
0/33
|
|
General disorders
Dystonia
|
0.00%
0/57
|
1.6%
1/64
|
0.00%
0/23
|
0.00%
0/60
|
0.00%
0/50
|
2.4%
1/41
|
3.0%
1/33
|
|
General disorders
Epileptic exacerbation
|
0.00%
0/57
|
0.00%
0/64
|
0.00%
0/23
|
0.00%
0/60
|
0.00%
0/50
|
0.00%
0/41
|
3.0%
1/33
|
|
General disorders
Extrapyramidal syndrome
|
0.00%
0/57
|
7.8%
5/64
|
13.0%
3/23
|
5.0%
3/60
|
0.00%
0/50
|
0.00%
0/41
|
81.8%
27/33
|
|
General disorders
Hyperprolactinemia
|
0.00%
0/57
|
0.00%
0/64
|
0.00%
0/23
|
0.00%
0/60
|
0.00%
0/50
|
4.9%
2/41
|
3.0%
1/33
|
|
General disorders
Hypertension
|
0.00%
0/57
|
0.00%
0/64
|
0.00%
0/23
|
0.00%
0/60
|
0.00%
0/50
|
2.4%
1/41
|
0.00%
0/33
|
|
General disorders
Weight gain
|
3.5%
2/57
|
3.1%
2/64
|
4.3%
1/23
|
20.0%
12/60
|
12.0%
6/50
|
2.4%
1/41
|
0.00%
0/33
|
|
General disorders
Weight gain + QT extension
|
0.00%
0/57
|
0.00%
0/64
|
0.00%
0/23
|
0.00%
0/60
|
2.0%
1/50
|
0.00%
0/41
|
0.00%
0/33
|
|
General disorders
Weight gain + Sedation
|
1.8%
1/57
|
0.00%
0/64
|
0.00%
0/23
|
0.00%
0/60
|
4.0%
2/50
|
0.00%
0/41
|
0.00%
0/33
|
|
General disorders
Leucopenia
|
0.00%
0/57
|
1.6%
1/64
|
0.00%
0/23
|
0.00%
0/60
|
0.00%
0/50
|
0.00%
0/41
|
0.00%
0/33
|
|
General disorders
Sedation
|
0.00%
0/57
|
1.6%
1/64
|
4.3%
1/23
|
10.0%
6/60
|
4.0%
2/50
|
2.4%
1/41
|
3.0%
1/33
|
|
General disorders
Late Dischinesia
|
0.00%
0/57
|
0.00%
0/64
|
0.00%
0/23
|
1.7%
1/60
|
0.00%
0/50
|
2.4%
1/41
|
6.1%
2/33
|
|
General disorders
Tremor
|
0.00%
0/57
|
1.6%
1/64
|
0.00%
0/23
|
3.3%
2/60
|
0.00%
0/50
|
2.4%
1/41
|
6.1%
2/33
|
|
General disorders
Tremor + Insomnia
|
0.00%
0/57
|
0.00%
0/64
|
0.00%
0/23
|
1.7%
1/60
|
0.00%
0/50
|
0.00%
0/41
|
0.00%
0/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER