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| ID | Type | Description | Link |
|---|---|---|---|
| NARSAD |
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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
| Pfizer | INDUSTRY |
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The objective of this study is to determine the effect of various mood stabilizers (MS) on the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in patients treated with antipsychotic drugs (APDs). Patients will be switched from their current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless clinically contraindicated) for comparison with metabolic levels during treatment with the former medication.
The metabolic syndrome is an empirical concept based on extensive evidence that a constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | aripiprazole (Abilify) |
|
| 2 | Active Comparator | ziprasidone (Geodon) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ziprasidone vs. aripiprazole | Drug | ziprasidone vs. aripiprazole dosed according to package insert |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HDL Ratio | change in HDL ratio after medication switch | 24 weeks from Baseline |
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Inclusion criteria
To be eligible, patients must :
A patient will be considered ineligible if he/she:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Yuejin Chen, M.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Hospital at Vanderbilt | Nashville | Tennessee | 37212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | aripiprazole (Abilify) ziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert |
| FG001 | Ziprasidone | ziprasidone (Geodon) aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | aripiprazole (Abilify) ziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert |
| BG001 | Ziprasidone |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | HDL Ratio | change in HDL ratio after medication switch | Posted | Mean | Standard Error | unit of Measure ''g/dL'' | 24 weeks from 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 | Aripiprazole | aripiprazole (Abilify) ziprasidone vs. aripiprazole: ziprasidone vs. aripiprazole dosed according to package insert aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of psychiatric symptoms | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Herbert Y Meltzer | Northwestern University | 1 312 503 0309 | h-meltzer@northwestern.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| aripiprazole vs. ziprasidone |
| Drug |
aripiprazole vs. ziprasidone dosed according to package insert |
|
ziprasidone (Geodon) aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | Ziprasidone | ziprasidone (Geodon) aripiprazole vs. ziprasidone: aripiprazole vs. ziprasidone dosed according to package insert | 0 | 26 | 0 | 26 | 0 | 26 |
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| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |