An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics
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A MULTI-CENTER, NON-INVASIVE OBSERVATIONAL STUDY OF METABOLIC SYNDROME PARAMETERS IN SCHIZOPHRENIC PATIENTS USING ATYPICAL ANTIPSYCHOTICS
1 other identifier
observational
328
1 country
47
Brief Summary
The purpose of the study is to find and follow-up the metabolic syndrome parameters on patients administering atypical antipsychotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2007
Shorter than P25 for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2007
CompletedFirst Posted
Study publicly available on registry
March 19, 2007
CompletedStudy Start
First participant enrolled
October 23, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2008
CompletedResults Posted
Study results publicly available
July 7, 2010
CompletedMay 3, 2022
April 1, 2022
9 months
March 16, 2007
July 27, 2009
April 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
Iterative measurement of triglycerides. Mean at time points
Baseline, 1 Month, 4 Months
Secondary Outcomes (4)
Metabolic Syndrome Parameter BMI by Treatment Group
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Weight by Treatment Group
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Waist Circumference by Treatment Group
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Triglycerides by Treatment Group
Baseline, 1 Month, 4 Months
Study Arms (1)
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.
Interventions
Non-interventional study
Eligibility Criteria
* 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.
You may qualify if:
- 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.
You may not qualify if:
- Patients who are pregnant or considering pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Adana Psychiatry and Neurology Hospital
Kurttepe, Adana, 01360, Turkey (Türkiye)
Pfizer Investigational Site
Kurttepe, Adana, 01360, Turkey (Türkiye)
Adana Psychiatry and Neurology Hospital
Adana, Turkey (Türkiye)
Cukurova University Scool of Medicine
Adana, Turkey (Türkiye)
Pfizer Investigational Site
Adana, Turkey (Türkiye)
Ankara Oncology Research and Training Hospital
Ankara, 06200, Turkey (Türkiye)
Pfizer Investigational Site
Ankara, 06200, Turkey (Türkiye)
Ankara Diskapi Training and Research Hospital
Ankara, Turkey (Türkiye)
Ankara Numune Research Hospital
Ankara, Turkey (Türkiye)
Ankara Numune Training and Research Hospital Department of Psychiatry
Ankara, Turkey (Türkiye)
Pfizer Investigational Site
Ankara, Turkey (Türkiye)
Antakya Mustafa Kemal University School of Medicine
Antakya, Turkey (Türkiye)
Pfizer Investigational Site
Antakya, Turkey (Türkiye)
Bolu Psychiatry and Neurology Hospital
Bolu, Turkey (Türkiye)
Pfizer Investigational Site
Bolu, Turkey (Türkiye)
Pamukkale University School Of Medicine
Denizli, Turkey (Türkiye)
Pfizer Investigational Site
Denizli, Turkey (Türkiye)
Elazig Mental Illness And Diseases Hospital
Elâzığ, Turkey (Türkiye)
Pfizer Investigational Site
Elâzığ, Turkey (Türkiye)
Eskisehir Osmangazi University
Eskişehir, Turkey (Türkiye)
Pfizer Investigational Site
Eskişehir, Turkey (Türkiye)
Bakirkoy Psychiatry and Neurology Hospital
Istanbul, 34147, Turkey (Türkiye)
Pfizer Investigational Site
Istanbul, 34147, Turkey (Türkiye)
Bakirkoy Mental Health Hospital, First Clinic of Neurosis
Istanbul, Turkey (Türkiye)
Bakirkoy Psychiatry and Neurology Hospital
Istanbul, Turkey (Türkiye)
Cerrahpasa School of Medicine
Istanbul, Turkey (Türkiye)
Erenkoy Psychology and neurology hospital
Istanbul, Turkey (Türkiye)
Istanbul University Istanbul School of Medicine
Istanbul, Turkey (Türkiye)
Marmara School of Medicine
Istanbul, Turkey (Türkiye)
Pfizer Investigational Site
Istanbul, Turkey (Türkiye)
Sisli Etfal Research and training Hospital
Istanbul, Turkey (Türkiye)
Vakif Gureba Hospital, Department of Psychiatry
Istanbul, Turkey (Türkiye)
Ege University School Of Medicine
Izmir, Turkey (Türkiye)
Pfizer Investigational Site
Izmir, Turkey (Türkiye)
Kayseri Public Hospital
Kayseri, Turkey (Türkiye)
Pfizer Investigational Site
Kayseri, Turkey (Türkiye)
Pfizer Investigational Site
Konya, Turkey (Türkiye)
Selcuk University Medical School Department of Psychiatry
Konya, Turkey (Türkiye)
Manisa Mental Illness And Diseases Hospital
Manisa, Turkey (Türkiye)
Pfizer Investigational Site
Manisa, Turkey (Türkiye)
19 may University School of Medicine
Samsun, Turkey (Türkiye)
Pfizer Investigational Site
Samsun, Turkey (Türkiye)
Samsun Mental Illness And Diseases Hospital
Samsun, Turkey (Türkiye)
Pfizer Investigational Site
Trabzon, Turkey (Türkiye)
Trabzon Numune Research Hospital
Trabzon, Turkey (Türkiye)
Pfizer Investigational Site
Trakya, Turkey (Türkiye)
Trakya University School of Medicine
Trakya, Turkey (Türkiye)
Related Links
Biospecimen
Whole blood (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride levels)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2007
First Posted
March 19, 2007
Study Start
October 23, 2007
Primary Completion
July 30, 2008
Study Completion
July 30, 2008
Last Updated
May 3, 2022
Results First Posted
July 7, 2010
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.