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

April 29, 2022 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A MULTI-CENTER, NON-INVASIVE OBSERVATIONAL STUDY OF METABOLIC SYNDROME PARAMETERS IN SCHIZOPHRENIC PATIENTS USING ATYPICAL ANTIPSYCHOTICS

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

328

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey
        • Pfizer Investigational Site
      • Adana, Turkey
        • Adana Psychiatry and Neurology Hospital
      • Adana, Turkey
        • Cukurova University Scool of Medicine
      • Ankara, Turkey
        • Pfizer Investigational Site
      • Ankara, Turkey, 06200
        • Pfizer Investigational Site
      • Ankara, Turkey, 06200
        • Ankara Oncology Research and Training Hospital
      • Ankara, Turkey
        • Ankara Diskapi Training and Research Hospital
      • Ankara, Turkey
        • Ankara Numune Research Hospital
      • Ankara, Turkey
        • Ankara Numune Training and Research Hospital Department of Psychiatry
      • Antakya, Turkey
        • Antakya Mustafa Kemal University School of Medicine
      • Antakya, Turkey
        • Pfizer Investigational Site
      • Bolu, Turkey
        • Pfizer Investigational Site
      • Bolu, Turkey
        • Bolu Psychiatry and Neurology Hospital
      • Denizli, Turkey
        • Pamukkale University School Of Medicine
      • Denizli, Turkey
        • Pfizer Investigational Site
      • Elazig, Turkey
        • Elazig Mental Illness And Diseases Hospital
      • Elazig, Turkey
        • Pfizer Investigational Site
      • Eskisehir, Turkey
        • Eskisehir Osmangazi University
      • Eskisehir, Turkey
        • Pfizer Investigational Site
      • Istanbul, Turkey
        • Pfizer Investigational Site
      • Istanbul, Turkey
        • Istanbul University Istanbul School of Medicine
      • Istanbul, Turkey
        • Cerrahpasa School of Medicine
      • Istanbul, Turkey, 34147
        • Bakirkoy Psychiatry and Neurology Hospital
      • Istanbul, Turkey, 34147
        • Pfizer Investigational Site
      • Istanbul, Turkey
        • Bakirkoy Mental Health Hospital, First Clinic of Neurosis
      • Istanbul, Turkey
        • Bakirkoy Psychiatry and Neurology Hospital
      • Istanbul, Turkey
        • Erenkoy Psychology and neurology hospital
      • Istanbul, Turkey
        • Marmara School of Medicine
      • Istanbul, Turkey
        • Sisli Etfal Research and Training Hospital
      • Istanbul, Turkey
        • Vakif Gureba Hospital, Department of Psychiatry
      • Izmir, Turkey
        • Pfizer Investigational Site
      • Izmir, Turkey
        • Ege University School of Medicine
      • Kayseri, Turkey
        • Kayseri Public Hospital
      • Kayseri, Turkey
        • Pfizer Investigational Site
      • Konya, Turkey
        • Pfizer Investigational Site
      • Konya, Turkey
        • Selcuk University Medical School Department of Psychiatry
      • Manisa, Turkey
        • Pfizer Investigational Site
      • Manisa, Turkey
        • Manisa Mental Illness And Diseases Hospital
      • Samsun, Turkey
        • Pfizer Investigational Site
      • Samsun, Turkey
        • 19 may University School of Medicine
      • Samsun, Turkey
        • Samsun Mental Illness And Diseases Hospital
      • Trabzon, Turkey
        • Pfizer Investigational Site
      • Trabzon, Turkey
        • Trabzon Numune Research Hospital
      • Trakya, Turkey
        • Pfizer Investigational Site
      • Trakya, Turkey
        • Trakya University School of Medicine
    • Adana
      • Kurttepe, Adana, Turkey, 01360
        • Adana Psychiatry and Neurology Hospital
      • Kurttepe, Adana, Turkey, 01360
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic Syndrome Parameter Body Mass Index (BMI)
Time Frame: Baseline, 1 Month, 4 Months
Iterative mean Body Mass Index at time points.
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Body Weight
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of body weight. Mean at time points.
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Waist Circumference
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of waist circumference. Mean at timepoints.
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Fasting Blood Sugar
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of fasting blood sugar. Mean at time points.
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Total Cholesterol
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of total cholesterol. Mean at time points.
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of LDL. Mean at time points
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter High Density Lipoprotein (HDL)
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of HDL. Mean at time points
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Triglycerides
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of triglycerides. Mean at time points
Baseline, 1 Month, 4 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic Syndrome Parameter BMI by Treatment Group
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of BMI. Mean at time points.
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Weight by Treatment Group
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of weight. Mean at time points.
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Waist Circumference by Treatment Group
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of waist circumference. Mean at time points.
Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Triglycerides by Treatment Group
Time Frame: Baseline, 1 Month, 4 Months
Iterative measurement of triglycerides. Mean at time points.
Baseline, 1 Month, 4 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2007

Primary Completion (Actual)

July 30, 2008

Study Completion (Actual)

July 30, 2008

Study Registration Dates

First Submitted

March 16, 2007

First Submitted That Met QC Criteria

March 16, 2007

First Posted (Estimate)

March 19, 2007

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1281160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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