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Completed

NCT Number: NCT00448630

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

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

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Key information

Conditions

Schizophrenia Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutritional and Metabolic Diseases Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Adana Psychiatry and Neurology Hospital, Kurttepe, Adana, Turkey (Türkiye)

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Non-interventional study

Primary outcomes

  1. Metabolic Syndrome Parameter Body Mass Index (BMI)

    Time frame: Baseline, 1 Month, 4 Months

    Iterative mean Body Mass Index at time points.

  2. Metabolic Syndrome Parameter Body Weight

    Time frame: Baseline, 1 Month, 4 Months

    Iterative measurement of body weight. Mean at time points.

  3. Metabolic Syndrome Parameter Waist Circumference

    Time frame: Baseline, 1 Month, 4 Months

    Iterative measurement of waist circumference. Mean at timepoints.

  4. Metabolic Syndrome Parameter Fasting Blood Sugar

    Time frame: Baseline, 1 Month, 4 Months

    Iterative measurement of fasting blood sugar. Mean at time points.

  5. Metabolic Syndrome Parameter Total Cholesterol

    Time frame: Baseline, 1 Month, 4 Months

    Iterative measurement of total cholesterol. Mean at time points.

  6. Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)

    Time frame: Baseline, 1 Month, 4 Months

    Iterative measurement of LDL. Mean at time points

  7. Metabolic Syndrome Parameter High Density Lipoprotein (HDL)

    Time frame: Baseline, 1 Month, 4 Months

    Iterative measurement of HDL. Mean at time points

  8. Metabolic Syndrome Parameter Triglycerides

    Time frame: Baseline, 1 Month, 4 Months

    Iterative measurement of triglycerides. Mean at time points

Secondary outcomes

  1. Metabolic Syndrome Parameter BMI by Treatment Group

    Time frame: Baseline, 1 Month, 4 Months

    Iterative measurement of BMI. Mean at time points.

  2. Metabolic Syndrome Parameter Weight by Treatment Group

    Time frame: Baseline, 1 Month, 4 Months

    Iterative measurement of weight. Mean at time points.

  3. Metabolic Syndrome Parameter Waist Circumference by Treatment Group

    Time frame: Baseline, 1 Month, 4 Months

    Iterative measurement of waist circumference. Mean at time points.

  4. Metabolic Syndrome Parameter Triglycerides by Treatment Group

    Time frame: Baseline, 1 Month, 4 Months

    Iterative measurement of triglycerides. Mean at time points.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Acronym: MESSAGE

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 19, 2007
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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