An Observational Study On Metabolic Syndrome Parameters I... | NCT00448630

NCT00448630

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atypical Antispychotics (or second generation antipsychotics)		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

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	Non-interventional study	Atypical Antispychotics (or second generation antipsychotics)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Adana Psychiatry and Neurology Hospital		Kurttepe	Adana	01360	Turkey (Türkiye)
Pfizer Investigational Site

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

No data available

No data is available for this block.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00037.7± 10.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000206
Male	BG000122

Region of Enrollment

Number

participants

Title

Denominators

Categories

Turkey

Title	Measurements
	BG000328

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Metabolic Syndrome Parameter Body Mass Index (BMI)

Iterative mean Body Mass Index at time points.

Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.

Posted

Mean

Standard Deviation

kg/m*m (kilograms per meter squared)

Baseline, 1 Month, 4 Months

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000163

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00026.3± 16.7

1 Month

Title	Measurements
	OG00026.6± 16.3

4 Months

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.	Friedman		<0.001	P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.						95							Superiority or Other (legacy)

Secondary

Metabolic Syndrome Parameter BMI by Treatment Group

Iterative measurement of BMI. Mean at time points.

Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.

Posted

Mean

Standard Deviation

kg/m*m

Baseline, 1 Month, 4 Months

ID	Title	Description
OG000	Ziprasidone	ziprasidone as prescribed by subject's physician
OG001	Risperidone	risperidone as prescribed by subject's physician
OG002	Quetiapine	quetiapine as prescribed by subject's physician
OG003	Olanzipine	olanzipine as prescribed by subject's physician
OG004	Aripiprazole	aripiprazole as prescribed by subject's physician

Primary

Metabolic Syndrome Parameter Body Weight

Iterative measurement of body weight. Mean at time points.

Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.

Posted

Mean

Standard Deviation

kg (kilogram)

Baseline, 1 Month, 4 Months

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Primary

Metabolic Syndrome Parameter Waist Circumference

Iterative measurement of waist circumference. Mean at timepoints.

Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.

Posted

Mean

Standard Deviation

cm (centimeter)

Baseline, 1 Month, 4 Months

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Primary

Metabolic Syndrome Parameter Fasting Blood Sugar

Iterative measurement of fasting blood sugar. Mean at time points.

Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.

Posted

Mean

Standard Deviation

mg/dl (miligrams per deciliter)

Baseline, 1 Month, 4 Months

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Primary

Metabolic Syndrome Parameter Total Cholesterol

Iterative measurement of total cholesterol. Mean at time points.

Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.

Posted

Mean

Standard Deviation

mg/dl

Baseline, 1 Month, 4 Months

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Primary

Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)

Iterative measurement of LDL. Mean at time points

Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.

Posted

Mean

Standard Deviation

mg/dl

Baseline, 1 Month, 4 Months

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Primary

Metabolic Syndrome Parameter High Density Lipoprotein (HDL)

Iterative measurement of HDL. Mean at time points

Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.

Posted

Mean

Standard Deviation

mg/dl

Baseline, 1 Month, 4 Months

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Primary

Metabolic Syndrome Parameter Triglycerides

Iterative measurement of triglycerides. Mean at time points

Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.

Posted

Mean

Standard Deviation

mg/dl

Baseline, 1 Month, 4 Months

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Metabolic Syndrome Parameter Weight by Treatment Group

Iterative measurement of weight. Mean at time points.

Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.

Posted

Mean

Standard Deviation

Baseline, 1 Month, 4 Months

ID	Title	Description
OG000	Ziprasidone	ziprasidone as prescribed by subject's physician
OG001	Risperidone	risperidone as prescribed by subject's physician
OG002	Quetiapine	quetiapine as prescribed by subject's physician
OG003	Olanzipine	olanzipine as prescribed by subject's physician
OG004	Aripiprazole	aripiprazole as prescribed by subject's physician

Secondary

Metabolic Syndrome Parameter Waist Circumference by Treatment Group

Iterative measurement of waist circumference. Mean at time points.

Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.

Posted

Mean

Standard Deviation

cm (centimeter)

Baseline, 1 Month, 4 Months

ID	Title	Description
OG000	Ziprasidone	ziprasidone as prescribed by subject's physician
OG001	Risperidone	risperidone as prescribed by subject's physician
OG002	Quetiapine	quetiapine as prescribed by subject's physician
OG003	Olanzipine	olanzipine as prescribed by subject's physician
OG004	Aripiprazole	aripiprazole as prescribed by subject's physician

Secondary

Metabolic Syndrome Parameter Triglycerides by Treatment Group

Iterative measurement of triglycerides. Mean at time points.

Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.

Posted

Mean

Standard Deviation

mg/dl

Baseline, 1 Month, 4 Months

ID	Title	Description
OG000	Ziprasidone	ziprasidone as prescribed by subject's physician
OG001	Risperidone	risperidone as prescribed by subject's physician
OG002	Quetiapine	quetiapine as prescribed by subject's physician
OG003	Olanzipine	olanzipine as prescribed by subject's physician
OG004	Aripiprazole	aripiprazole as prescribed by subject's physician

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ziprasidone	ziprasidone as prescribed by subject's physician	57	4	57
EG001	Risperidone	risperidone as prescribed by subject's physician	64	14	64
EG002	Quetiapine	quetiapine as prescribed by subject's physician	23	5	23
EG003	Olanzipine	olanzipine as prescribed by subject's physician	60	27	60
EG004	Aripiprazole	aripiprazole as prescribed by subject's physician	50	12	50
EG005	Amisulpride	amisulpride as prescribed by subject's physician	41	9	41
EG006	Other	other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.	33	33	33

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Menstrual irregularities	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG0031 affected60 at risk EG0040 affected50 at risk EG0050 affected41 at risk EG0060 affected33 at risk
Mouth dryness	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG003
Akathisia	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0011 affected64 at risk EG0020 affected23 at risk EG003
Akathisia + sedation	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0011 affected64 at risk EG0020 affected23 at risk EG003
Allergy + Sedation	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0011 affected64 at risk EG0020 affected23 at risk EG003
Giddiness	General disorders	Non-systematic Assessment	EG0001 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG003
Nausea	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG003
Dyspahlgia	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG003
Dystasia	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG003
Dystonia	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0011 affected64 at risk EG0020 affected23 at risk EG003
Epileptic exacerbation	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG003
Extrapyramidal syndrome	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0015 affected64 at risk EG0023 affected23 at risk EG003
Hyperprolactinemia	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG003
Hypertension	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG003
Weight gain	General disorders	Non-systematic Assessment	EG0002 affected57 at risk EG0012 affected64 at risk EG0021 affected23 at risk EG003
Weight gain + QT extension	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG003
Weight gain + Sedation	General disorders	Non-systematic Assessment	EG0001 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG003
Leucopenia	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0011 affected64 at risk EG0020 affected23 at risk EG003
Sedation	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0011 affected64 at risk EG0021 affected23 at risk EG003
Late Dischinesia	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG003
Tremor	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0011 affected64 at risk EG0020 affected23 at risk EG003
Tremor + Insomnia	General disorders	Non-systematic Assessment	EG0000 affected57 at risk EG0010 affected64 at risk EG0020 affected23 at risk EG003

ID	Term
D012559	Schizophrenia
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Title	Measurements
	OG00026.9± 17.8

EG0040 affected50 at risk

EG0050 affected41 at risk

EG0061 affected33 at risk

EG0040 affected50 at risk

EG0050 affected41 at risk

EG0065 affected33 at risk

EG0040 affected50 at risk

EG0050 affected41 at risk

EG0060 affected33 at risk

EG0040 affected50 at risk

EG0050 affected41 at risk

EG0060 affected33 at risk

EG0040 affected50 at risk

EG0050 affected41 at risk

EG0060 affected33 at risk

EG0040 affected50 at risk

EG0051 affected41 at risk

EG0060 affected33 at risk

EG0040 affected50 at risk

EG0050 affected41 at risk

EG0061 affected33 at risk

EG0041 affected50 at risk

EG0050 affected41 at risk

EG0060 affected33 at risk

EG0040 affected50 at risk

EG0051 affected41 at risk

EG0061 affected33 at risk

EG0040 affected50 at risk

EG0050 affected41 at risk

EG0061 affected33 at risk

EG0040 affected50 at risk

EG0050 affected41 at risk

EG00627 affected33 at risk

EG0040 affected50 at risk

EG0052 affected41 at risk

EG0061 affected33 at risk

EG0040 affected50 at risk

EG0051 affected41 at risk

EG0060 affected33 at risk

EG0046 affected50 at risk

EG0051 affected41 at risk

EG0060 affected33 at risk

EG0041 affected50 at risk

EG0050 affected41 at risk

EG0060 affected33 at risk

EG0042 affected50 at risk

EG0050 affected41 at risk

EG0060 affected33 at risk

EG0040 affected50 at risk

EG0050 affected41 at risk

EG0060 affected33 at risk

EG0042 affected50 at risk

EG0051 affected41 at risk

EG0061 affected33 at risk

EG0040 affected50 at risk

EG0051 affected41 at risk

EG0062 affected33 at risk

EG0040 affected50 at risk

EG0051 affected41 at risk

EG0062 affected33 at risk

EG0040 affected50 at risk

EG0050 affected41 at risk

EG0060 affected33 at risk

OG005161.85± 143.26