Clinical trial NCT00448630: An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics
Official title: A MULTI-CENTER, NON-INVASIVE OBSERVATIONAL STUDY OF METABOLIC SYNDROME PARAMETERS IN SCHIZOPHRENIC PATIENTS USING ATYPICAL ANTIPSYCHOTICS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Metabolic Syndrome X
Keywords: Atypical antipsychotics
Metabolic syndrome
Safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Female and male patients diagnosed as schizophrenia by DSM-IV criteria; 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 in psychiatry clinics in state and university hospitals.

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.

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.

Primary outcomes:
measure: Metabolic Syndrome Parameter Body Mass Index (BMI)
timeFrame: Baseline, 1 Month, 4 Months
measure: Metabolic Syndrome Parameter Body Weight
timeFrame: Baseline, 1 Month, 4 Months
measure: Metabolic Syndrome Parameter Waist Circumference
timeFrame: Baseline, 1 Month, 4 Months
measure: Metabolic Syndrome Parameter Fasting Blood Sugar
timeFrame: Baseline, 1 Month, 4 Months
measure: Metabolic Syndrome Parameter Total Cholesterol
timeFrame: Baseline, 1 Month, 4 Months
measure: Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)
timeFrame: Baseline, 1 Month, 4 Months
measure: Metabolic Syndrome Parameter High Density Lipoprotein (HDL)
timeFrame: Baseline, 1 Month, 4 Months
measure: Metabolic Syndrome Parameter Triglycerides
timeFrame: Baseline, 1 Month, 4 Months
Secondary outcomes:
measure: Metabolic Syndrome Parameter BMI by Treatment Group
timeFrame: Baseline, 1 Month, 4 Months
measure: Metabolic Syndrome Parameter Weight by Treatment Group
timeFrame: Baseline, 1 Month, 4 Months
measure: Metabolic Syndrome Parameter Waist Circumference by Treatment Group
timeFrame: Baseline, 1 Month, 4 Months
measure: Metabolic Syndrome Parameter Triglycerides by Treatment Group
timeFrame: Baseline, 1 Month, 4 Months
Other outcomes:
Locations:
city: Kurttepe
country: Turkey
facility: Adana Psychiatry and Neurology Hospital
state: Adana
city: Kurttepe
country: Turkey
facility: Pfizer Investigational Site
state: Adana
city: Adana
country: Turkey
facility: Adana Psychiatry and Neurology Hospital
city: Adana
country: Turkey
facility: Cukurova University Scool of Medicine
city: Adana
country: Turkey
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Ankara Oncology Research and Training Hospital
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Ankara Diskapi Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Numune Research Hospital
city: Ankara
country: Turkey
facility: Ankara Numune Training and Research Hospital Department of Psychiatry
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Antakya
country: Turkey
facility: Antakya Mustafa Kemal University School of Medicine
city: Antakya
country: Turkey
facility: Pfizer Investigational Site
city: Bolu
country: Turkey
facility: Bolu Psychiatry and Neurology Hospital
city: Bolu
country: Turkey
facility: Pfizer Investigational Site
city: Denizli
country: Turkey
facility: Pamukkale University School Of Medicine
city: Denizli
country: Turkey
facility: Pfizer Investigational Site
city: Elazig
country: Turkey
facility: Elazig Mental Illness And Diseases Hospital
city: Elazig
country: Turkey
facility: Pfizer Investigational Site
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
city: Eskisehir
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Bakirkoy Psychiatry and Neurology Hospital
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Bakirkoy Mental Health Hospital, First Clinic of Neurosis
city: Istanbul
country: Turkey
facility: Bakirkoy Psychiatry and Neurology Hospital
city: Istanbul
country: Turkey
facility: Cerrahpasa School of Medicine
city: Istanbul
country: Turkey
facility: Erenkoy Psychology and neurology hospital
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul School of Medicine
city: Istanbul
country: Turkey
facility: Marmara School of Medicine
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Sisli Etfal Research and training Hospital
city: Istanbul
country: Turkey
facility: Vakif Gureba Hospital, Department of Psychiatry
city: Izmir
country: Turkey
facility: Ege University School Of Medicine
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Kayseri
country: Turkey
facility: Kayseri Public Hospital
city: Kayseri
country: Turkey
facility: Pfizer Investigational Site
city: Konya
country: Turkey
facility: Pfizer Investigational Site
city: Konya
country: Turkey
facility: Selcuk University Medical School Department of Psychiatry
city: Manisa
country: Turkey
facility: Manisa Mental Illness And Diseases Hospital
city: Manisa
country: Turkey
facility: Pfizer Investigational Site
city: Samsun
country: Turkey
facility: 19 may University School of Medicine
city: Samsun
country: Turkey
facility: Pfizer Investigational Site
city: Samsun
country: Turkey
facility: Samsun Mental Illness And Diseases Hospital
city: Trabzon
country: Turkey
facility: Pfizer Investigational Site
city: Trabzon
country: Turkey
facility: Trabzon Numune Research Hospital
city: Trakya
country: Turkey
facility: Pfizer Investigational Site
city: Trakya
country: Turkey
facility: Trakya University School of Medicine
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: