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| ID | Type | Description | Link |
|---|---|---|---|
| 124932 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stay on current antipsychotic | No Intervention | Subjects stay on same daily oral antipsychotic treatment as at baseline. Dose adjustments allowable as clinically indicated. | |
| ziprasidone treatment | Active Comparator | Subjects switch to daily oral ziprasidone from current antipsychotic(s). Dose titrated to clinically effective level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ziprasidone | Drug | Patients assigned to ziprasidone arm are cross-titrated from current antipsychotic |
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| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | Euglycemic clamp method | Baseline |
| Insulin Sensitivity | Euglycemic clamp method | 4-5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Baseline | |
| Body Mass Index | 4-5 months | |
| Abdominal Circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALEXANDER L MILLER, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center At San Antonio | San Antonio | Texas | 78229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stay on Current Antipsychotic | Subjects stay on same antipsychotic treatment as at baseline. |
| FG001 | Ziprasidone Treatment | Subjects switch to ziprasidone from current antipsychotic(s) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stay on Current Antipsychotic | Subjects stay on same antipsychotic treatment as at baseline. |
| BG001 | Ziprasidone Treatment | Subjects switch to ziprasidone from current antipsychotic(s) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin Sensitivity | Euglycemic clamp method | Posted | Mean | Standard Deviation | mg glucose/kg.min/μIU insulin | Baseline |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stay on Current Antipsychotic | Subjects stay on same antipsychotic treatment as at baseline. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexander Miller | University of Texas Health Science Center at San Antonio | 210-567-5508 | millera@uthscsa.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Body Mass Index | Posted | Mean | Standard Deviation | Kg/m2 | Baseline |
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| Secondary | Body Mass Index | Posted | Mean | Standard Deviation | Kg/m2 | 4-5 months |
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| Secondary | Abdominal Circumference | Posted | Mean | Standard Deviation | cm | Baseline |
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| Secondary | Abdominal Circumference | Posted | Mean | Standard Deviation | cm | 4-5 months |
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| Secondary | Systolic Blood Pressure | Posted | Mean | Standard Deviation | mm Hg | Baseline |
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| Secondary | Systolic Blood Pressure | Posted | Mean | Standard Deviation | mm Hg | 4-5 months |
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| Secondary | Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mm Hg | Baseline |
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| Secondary | Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mm Hg | 4-5 months |
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| Secondary | Triglycerides | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Secondary | Triglycerides | Posted | Mean | Standard Deviation | mg/dL | 4-5 months |
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| Secondary | Cholesterol | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Secondary | Cholesterol | Posted | Mean | Standard Deviation | mg/dL | 4-5 months |
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| Secondary | HDL Cholesterol | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Secondary | HDL Cholesterol | Posted | Mean | Standard Deviation | mg/dL | 4-5 months |
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| Secondary | LDL Cholesterol | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Secondary | LDL Cholesterol | Posted | Mean | Standard Deviation | mg/dL | 4-5 months |
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| Primary | Insulin Sensitivity | Euglycemic clamp method | Posted | Mean | Standard Deviation | mg glucose/kg.min/μIU insulin | 4-5 months |
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| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Ziprasidone Treatment | Subjects switch to ziprasidone from current antipsychotic(s) | 0 | 14 | 0 | 14 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |