An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics (MESSAGE)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00448630
First received: March 16, 2007
Last updated: June 4, 2010
Last verified: June 2010
  Purpose

The purpose of the study is to find and follow-up the metabolic syndrome parameters on patients administering atypical antipsychotics.


Condition Intervention Phase
Schizophrenia
Metabolic Syndrome X
Other: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Center, Non-Interventional, Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Metabolic Syndrome Parameter Body Mass Index (BMI) [ Time Frame: Baseline, 1 Month, 4 Months ] [ Designated as safety issue: No ]
    Iterative mean Body Mass Index at time points.

  • Metabolic Syndrome Parameter Body Weight [ Time Frame: Baseline, 1 Month, 4 Months ] [ Designated as safety issue: No ]
    Iterative measurement of body weight. Mean at time points.

  • Metabolic Syndrome Parameter Waist Circumference [ Time Frame: Baseline, 1 Month, 4 Months ] [ Designated as safety issue: No ]
    Iterative measurement of waist circumference. Mean at timepoints.

  • Metabolic Syndrome Parameter Fasting Blood Sugar [ Time Frame: Baseline, 1 Month, 4 Months ] [ Designated as safety issue: No ]
    Iterative measurement of fasting blood sugar. Mean at time points.

  • Metabolic Syndrome Parameter Total Cholesterol [ Time Frame: Baseline, 1 Month, 4 Months ] [ Designated as safety issue: No ]
    Iterative measurement of total cholesterol. Mean at time points.

  • Metabolic Syndrome Parameter Low Density Lipoprotein (LDL) [ Time Frame: Baseline, 1 Month, 4 Months ] [ Designated as safety issue: No ]
    Iterative measurement of LDL. Mean at time points

  • Metabolic Syndrome Parameter High Density Lipoprotein (HDL) [ Time Frame: Baseline, 1 Month, 4 Months ] [ Designated as safety issue: No ]
    Iterative measurement of HDL. Mean at time points

  • Metabolic Syndrome Parameter Triglycerides [ Time Frame: Baseline, 1 Month, 4 Months ] [ Designated as safety issue: No ]
    Iterative measurement of triglycerides. Mean at time points


Secondary Outcome Measures:
  • Metabolic Syndrome Parameter BMI by Treatment Group [ Time Frame: Baseline, 1 Month, 4 Months ] [ Designated as safety issue: No ]
    Iterative measurement of BMI. Mean at time points.

  • Metabolic Syndrome Parameter Weight by Treatment Group [ Time Frame: Baseline, 1 Month, 4 Months ] [ Designated as safety issue: No ]
    Iterative measurement of weight. Mean at time points.

  • Metabolic Syndrome Parameter Waist Circumference by Treatment Group [ Time Frame: Baseline, 1 Month, 4 Months ] [ Designated as safety issue: No ]
    Iterative measurement of waist circumference. Mean at time points.

  • Metabolic Syndrome Parameter Triglycerides by Treatment Group [ Time Frame: Baseline, 1 Month, 4 Months ] [ Designated as safety issue: No ]
    Iterative measurement of triglycerides. Mean at time points.


Biospecimen Retention:   Samples With DNA

Whole blood (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride levels)


Enrollment: 328
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Non-interventional study

Detailed Description:

Sampling Method Details: Group of patients using the same atypical anti-psychotic.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448630

Locations
Turkey
Pfizer Investigational Site
Kurttepe, Adana, Turkey, 01360
Pfizer Investigational Site
Adana, Turkey
Pfizer Investigational Site
Ankara, Turkey
Pfizer Investigational Site
Ankara, Turkey, 06200
Pfizer Investigational Site
Antakya, Turkey
Pfizer Investigational Site
Bolu, Turkey
Pfizer Investigational Site
Denizli, Turkey
Pfizer Investigational Site
Elazig, Turkey
Pfizer Investigational Site
Eskisehir, Turkey
Pfizer Investigational Site
Istanbul, Turkey, 34147
Pfizer Investigational Site
Istanbul, Turkey
Pfizer Investigational Site
Izmir, Turkey
Pfizer Investigational Site
Kayseri, Turkey
Pfizer Investigational Site
Konya, Turkey
Pfizer Investigational Site
Manisa, Turkey
Pfizer Investigational Site
Samsun, Turkey
Pfizer Investigational Site
Trabzon, Turkey
Pfizer Investigational Site
Trakya, Turkey
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00448630     History of Changes
Other Study ID Numbers: A1281160
Study First Received: March 16, 2007
Results First Received: July 27, 2009
Last Updated: June 4, 2010
Health Authority: Turkey: Ministry of Health, Directory of Pharmacies and Pharmaceuticals

Keywords provided by Pfizer:
Atypical antipsychotics, Metabolic syndrome, Safety

Additional relevant MeSH terms:
Schizophrenia
Metabolic Syndrome X
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 26, 2014