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| ID | Type | Description | Link |
|---|---|---|---|
| NARSAD |
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unable to secure additional funding
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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
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The primary goal of this study is to examine the triglyceride/high-density lipoprotein (TG/HDL) ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.
The primary goal of this study is to examine the triglyceride/high-density lipoprotein (TG/HDL) ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder. The secondary goal is to identify those subjects in the top tertile for the highest risk of ischemic heart disease (IHD) as defined by TG/HDL ratios (>>3.5) and ischemic EKG changes with and without clinical ischemia, e.g. angina and to see if these risk factors can be reduced or reversed by a change of antipsychotic medication, dietary counseling, enrollment into available exercise groups, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | aripiprazole (Abilify) |
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| 2 | Active Comparator | ziprasidone (Geodon) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aripiprazole (Abilify) | Drug | active drug given daily as per package insert according to standard clinical care for twelve month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Triglyceride/High-density Lipoprotein (TG/HDL) Ratio | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | 24 weeks | |
| Body Mass Index (BMI) | 24 weeks | |
| Cholesterol |
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Inclusion criteria
To be eligible, a patient must :
Exclusion criteria
A patient will be considered ineligible if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Tianlai Tang, M.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt Psychiatric Hospital | Nashville | Tennessee | 37212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole (Abilify) | aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication. |
| FG001 | Ziprasidone (Geodon) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ziprasidone (Geodon) | Drug | active medication will be given daily as per package insert according to standard clinical care for the twelve month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication. |
|
| 24 weeks |
| High-Density Lipoprotein (HDL) | 24 weeks |
| Triglyceride (TG) | 24 weeks |
ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole (Abilify) | aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication. |
| BG001 | Ziprasidone (Geodon) | ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication. |
| BG002 | Total | Total of all reporting groups |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Hypertension, number | Count of Participants | Participants |
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| Type 2 Diabetes, number | Count of Participants | Participants |
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| Diagnosis of schizophrenia (SCH) and schizoaffective disorder (SCHAF) or bipolar disorder number | Count of Participants | Participants |
| ||||||||||||||||
| Positive and Negative Syndrome Scale (PANSS) Total Score | The Positive and Negative Syndrome Scale (PANSS) is a 30-item questionnaire for assessing severity of schizophrenia symptoms. The PANSS is divided into three subscales: positive symptoms, negative symptoms, and cognitive. Each item is rated on a 7-point scale, ranging from absent to extreme. Therefore, the minimum possible score of 0 and maximum possible score is 210, but those scores may never be seen in a practical setting. If the score reduces over time that indicates improvement of the symptoms. | Least Squares Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Positive and Negative Syndrome Scale (PANSS) Positive Score | Positive and Negative Syndrome Scale (PANSS) Positive scale; the scale consists of a sum of 7 items, so the score can range from 0 - 49. Improvement means lower scores over time | Least Squares Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Positive and Negative Syndrome Scale (PANSS) Negative Score | Positive and Negative Syndrome Scale (PANSS) Negative scale; the scale consists of a sum of 7 items, so the score can range from 0 - 49. Improvement means lower scores over time | Least Squares Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Positive and Negative Syndrome Scale (PANSS) Cognitive Score | Positive and Negative Syndrome Scale (PANSS) Positive scale; the scale consists of a sum of 16 items, so the score can range from 0 - 112. Improvement means lower scores over time | Least Squares Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Drug taken prior to enrollment | Count of Participants | Participants |
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| 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 | Triglyceride/High-density Lipoprotein (TG/HDL) Ratio | Posted | Least Squares Mean | Standard Error | (mg/dL)/(mg/dL) | 24 weeks |
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| Secondary | Weight | Posted | Least Squares Mean | Standard Error | lbs | 24 weeks |
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| Secondary | Body Mass Index (BMI) | Posted | Least Squares Mean | Standard Error | kg/m^2 | 24 weeks |
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| Secondary | Cholesterol | Posted | Least Squares Mean | Standard Error | mg/DL | 24 weeks |
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| Secondary | High-Density Lipoprotein (HDL) | Posted | Least Squares Mean | Standard Error | mg/dL | 24 weeks |
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| Secondary | Triglyceride (TG) | Posted | Least Squares Mean | Standard Error | mg/dL | 24 weeks |
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24 weeks
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
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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 (Abilify) | aripiprazole (Abilify): active drug given daily as per package insert according to standard clinical care for the twelve-month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | Ziprasidone (Geodon) | ziprasidone (Geodon): active medication will be given daily as per package insert according to standard clinical care for the twelve-month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication. | 0 | 23 | 0 | 23 | 0 | 23 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Herbert Meltzer | Northwestern University | (312) 503-0309 | h-meltzer@northwestern.edu |
| 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 |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| C092292 | ziprasidone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 12 weeks |
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| 24 weeks |
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