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

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Intervention / Treatment
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* Drug: ziprasidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Stay on current antipsychotic<br>Subjects stay on same daily oral antipsychotic treatment as at baseline. Dose adjustments allowable as clinically indicated. | |
| Active Comparator: ziprasidone treatment<br>Subjects switch to daily oral ziprasidone from current antipsychotic(s). Dose titrated to clinically effective level. | Drug: ziprasidone<br>* Patients assigned to ziprasidone arm are cross-titrated from current antipsychotic<br>* Other names: Geodon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity | Euglycemic clamp method | Baseline | 
| Insulin Sensitivity | Euglycemic clamp method | 4-5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index |  | Baseline | 
| Body Mass Index |  | 4-5 months | 
| Abdominal Circumference |  | Baseline | 
| Abdominal Circumference |  | 4-5 months | 
| Systolic Blood Pressure |  | Baseline | 
| Systolic Blood Pressure |  | 4-5 months | 
| Diastolic Blood Pressure |  | Baseline | 
| Diastolic Blood Pressure |  | 4-5 months | 
| Triglycerides |  | Baseline | 
| Triglycerides |  | 4-5 months | 
| Cholesterol |  | Baseline | 
| Cholesterol |  | 4-5 months | 
| HDL Cholesterol |  | Baseline | 
| HDL Cholesterol |  | 4-5 months | 
| LDL Cholesterol |  | Baseline | 
| LDL Cholesterol |  | 4-5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, antipsychotics, diabetes, bipolar disorder