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Completed

NCT Number: NCT00538642

Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone

Having a diagnosis of schizophrenia or bipolar disorder and being treated with certain of the newer antipsychotics are risk factors for development of diabetes. Subjects with these risk factors plus obesity and/or family history of diabetes who agree to study participation will undergo an oral glucose tolerance test. If the oral glucose tolerance test demonstrates that the subject is pre-diabetic (elevated glucose levels, but below the diabetic range), he/she will have his/her insulin resistance level measured, prior to random assignment to either stay on current antipsychotic medication or switch to ziprasidone. Insulin resistance will be measured again after four months. The primary hypothesis is that insulin resistance will decrease in those switched to ziprasidone relative to those continuing on their same antipsychotic medication.

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar and Related Disorders Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Mood Disorders Nutritional and Metabolic Diseases Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center At San Antonio

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder
  • BMI>29.9 or family history of diabetes and/or abdominal circumference greater than 88 cm in women or 102 cm in men
  • Pre-diabetic oral glucose tolerance test
  • Current treatment with olanzapine, risperidone, paliperidone, or quetiapine, or combination of these
  • Willing to switch to ziprasidone
  • No psychiatric hospitalizations in past three months and judged by treating clinician to be suitable for antipsychotic medication switch
  • Able to give informed consent to study

Exclusion criteria

  • Judged to be currently suicidal, homicidal, or unable to cooperate with treatment
  • Unstable serious medical illness
  • Current use of drugs that interfere with glucose and fat metabolism (sulfonylureas, metformin, thiazolidinediones). The use of "statins" and fibrates will be allowed ONLY if stable dose for past 3 months.
  • Current diagnosis of diabetes
  • Fasting blood glucose >125 mg/dl

Treatment and study plan

Ziprasidone

Drug

Patients assigned to ziprasidone arm are cross-titrated from current antipsychotic

Other names: Geodon

Primary outcomes

  1. Insulin Sensitivity

    Time frame: Baseline

    Euglycemic clamp method

  2. Insulin Sensitivity

    Time frame: 4-5 months

    Euglycemic clamp method

Secondary outcomes

  1. Body Mass Index

    Time frame: Baseline

  2. Body Mass Index

    Time frame: 4-5 months

  3. Abdominal Circumference

    Time frame: Baseline

  4. Abdominal Circumference

    Time frame: 4-5 months

  5. Systolic Blood Pressure

    Time frame: Baseline

  6. Systolic Blood Pressure

    Time frame: 4-5 months

  7. Diastolic Blood Pressure

    Time frame: Baseline

  8. Diastolic Blood Pressure

    Time frame: 4-5 months

  9. Triglycerides

    Time frame: Baseline

  10. Triglycerides

    Time frame: 4-5 months

  11. Cholesterol

    Time frame: Baseline

  12. Cholesterol

    Time frame: 4-5 months

  13. HDL Cholesterol

    Time frame: Baseline

  14. HDL Cholesterol

    Time frame: 4-5 months

  15. LDL Cholesterol

    Time frame: Baseline

  16. LDL Cholesterol

    Time frame: 4-5 months

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 3, 2007
Registry last updated
Nov 29, 2012

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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