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The study was terminated by the sponser due to low study enrollment.
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet with their study psychiatrist at least bi-monthly throughout their participation, more frequently when clinically necessary (e.g. during medication tapering or if manic/depressive symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough assessments will be conducted at Baseline, Week 2, and Month 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Aripiprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic. |
| Measure | Description | Time Frame |
|---|---|---|
| BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns), | 3 months | |
| Epworth Sleepiness Scale (General Level of Daytime Sleepiness) | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment of Functioning | 3 months | |
| Quality of Life Enjoyment Questionnaire | 3 months | |
| Young Mania Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Aripiprazole Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Aripiprazole Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic. |
| 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 | BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns), | 0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed. | Posted | 3 months |
|
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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 Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic. |
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the study was terminated early by the study sponsor due to low enrol...
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly Swartz, MD | University of Pittsburgh | 412-246-5588 | swartzha@upmc.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D024821 | Metabolic Syndrome |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D007333 | Insulin Resistance |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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|
|
| 3 months |
| Hamilton Rating Scale for Depression | 3 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Primary | Epworth Sleepiness Scale (General Level of Daytime Sleepiness) | 0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed. | Posted | 3 month |
|
|
| Secondary | Global Assessment of Functioning | Study was terminated early and data were not collected for this outcome. | Posted | 3 months |
|
|
| Secondary | Quality of Life Enjoyment Questionnaire | Study was terminated early and data were not collected for this outcome. | Posted | 3 months |
|
|
| Secondary | Young Mania Rating Scale | Study was terminated early and data were not collected for this outcome. | Posted | 3 months |
|
|
| Secondary | Hamilton Rating Scale for Depression | Study was terminated early and data were not collected for this outcome. | Posted | 3 months |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
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| D006946 |
| Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |