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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This research study is designed to determine if replacing your current antipsychotic and/or mood stabilizer with ziprasidone (Geodon) will impact weight. This research is being conducted because Geodon has a documented effect on mood. Additionally, we believe Geodon to be an effective medication for overweight or obese patients with bipolar disorder. There will be approximately 25 patients enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ziprasidone/Geodon | Experimental | Ziprasidone/Geodon up to 320 mg per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziprasidone/Geodon | Drug | Ziprasidone/Geodon |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Measure Was Weight Change From Baseline to Endpoint. | The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline to Endpoint in Body Mass Index (BMI) | Secondary outcome measures will include the change from baseline to endpoint in Body Mass Index (BMI). | Baseline, 12 weeks |
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Inclusion Criteria:Patients will meet the following criteria to be eligible to participate in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Terence Arthur Ketter | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| Label | URL |
|---|---|
| Stanford University Bipolar Disorders Clinic | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ziprasidone/Geodon | Ziprasidone/Geodon up to 320 mg per day Ziprasidone/Geodon: Ziprasidone/Geodon |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ziprasidone/Geodon | Ziprasidone/Geodon up to 320 mg per day Ziprasidone/Geodon: Ziprasidone/Geodon |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Primary Outcome Measure Was Weight Change From Baseline to Endpoint. | The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model. | Posted | Mean | Standard Deviation | Pounds | Baseline, 12 weeks |
|
|
12 weeks
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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 | Ziprasidone/Geodon | Ziprasidone/Geodon up to 320 mg per day Ziprasidone/Geodon: Ziprasidone/Geodon |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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The current study has noteworthy limitations, including a small sample size, short trial duration, and an open, uncontrolled design.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Po W. Wang | Stanford University School of Medicine | 650-723-2483 | wangp0@stanford.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants |
|
| Bipolar Subtype | Bipolar I is characterized by one or more manic episodes or mixed episodes. Typically a person will experience periods of depression as well. Bipolar I disorder is marked by manic episodes. Bipolar II disorder is diagnosed after one or more major depressive episodes and at least one episode of hypomania, with possible periods of level mood between episodes. Bipolar disorder that does not follow a particular pattern is called bipolar disorder Not Otherwise Specified (NOS). Diagnosis follows criteria put forth by the DSM-4 | Count of Participants | Participants | No |
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| Weight | Mean | Standard Deviation | pounds |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Waist Circumference | Mean | Standard Deviation | inches |
|
|
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| Secondary | Changes From Baseline to Endpoint in Body Mass Index (BMI) | Secondary outcome measures will include the change from baseline to endpoint in Body Mass Index (BMI). | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 12 weeks |
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|
|
|
| 3 |
| 25 |
| 0 |
| 25 |
| Loss of Consciousness | Vascular disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypomania | Psychiatric disorders | Systematic Assessment |
|
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