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Trial record 1 of 1 for:    NCT00448630
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An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics (MESSAGE)

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ClinicalTrials.gov Identifier: NCT00448630
Recruitment Status : Completed
First Posted : March 19, 2007
Results First Posted : July 7, 2010
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date March 16, 2007
First Posted Date March 19, 2007
Results First Submitted Date July 27, 2009
Results First Posted Date July 7, 2010
Last Update Posted Date July 7, 2010
Study Start Date October 2007
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2010)
  • Metabolic Syndrome Parameter Body Mass Index (BMI) [ Time Frame: Baseline, 1 Month, 4 Months ]
    Iterative mean Body Mass Index at time points.
  • Metabolic Syndrome Parameter Body Weight [ Time Frame: Baseline, 1 Month, 4 Months ]
    Iterative measurement of body weight. Mean at time points.
  • Metabolic Syndrome Parameter Waist Circumference [ Time Frame: Baseline, 1 Month, 4 Months ]
    Iterative measurement of waist circumference. Mean at timepoints.
  • Metabolic Syndrome Parameter Fasting Blood Sugar [ Time Frame: Baseline, 1 Month, 4 Months ]
    Iterative measurement of fasting blood sugar. Mean at time points.
  • Metabolic Syndrome Parameter Total Cholesterol [ Time Frame: Baseline, 1 Month, 4 Months ]
    Iterative measurement of total cholesterol. Mean at time points.
  • Metabolic Syndrome Parameter Low Density Lipoprotein (LDL) [ Time Frame: Baseline, 1 Month, 4 Months ]
    Iterative measurement of LDL. Mean at time points
  • Metabolic Syndrome Parameter High Density Lipoprotein (HDL) [ Time Frame: Baseline, 1 Month, 4 Months ]
    Iterative measurement of HDL. Mean at time points
  • Metabolic Syndrome Parameter Triglycerides [ Time Frame: Baseline, 1 Month, 4 Months ]
    Iterative measurement of triglycerides. Mean at time points
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: June 4, 2010)
  • Metabolic Syndrome Parameter BMI by Treatment Group [ Time Frame: Baseline, 1 Month, 4 Months ]
    Iterative measurement of BMI. Mean at time points.
  • Metabolic Syndrome Parameter Weight by Treatment Group [ Time Frame: Baseline, 1 Month, 4 Months ]
    Iterative measurement of weight. Mean at time points.
  • Metabolic Syndrome Parameter Waist Circumference by Treatment Group [ Time Frame: Baseline, 1 Month, 4 Months ]
    Iterative measurement of waist circumference. Mean at time points.
  • Metabolic Syndrome Parameter Triglycerides by Treatment Group [ Time Frame: Baseline, 1 Month, 4 Months ]
    Iterative measurement of triglycerides. Mean at time points.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics
Official Title A Multi-Center, Non-Interventional, Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride levels)
Sampling Method Non-Probability Sample
Study Population Female and male patients diagnosed as schizophrenia by DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) 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.
Condition
  • Schizophrenia
  • Metabolic Syndrome X
Intervention Other: No intervention
Non-interventional study
Study Groups/Cohorts 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.
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 4, 2010)
328
Original Enrollment
 (submitted: March 16, 2007)
450
Actual Study Completion Date July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
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.
  • Patients who were included in a similar study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT00448630
Other Study ID Numbers A1281160
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2010