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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator |
| |
| A2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline to endpoint on the MADRS total score. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression - Bipolar Version | ||
| Severity of illness score depression | ||
| Mean change from baseline to endpoint |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Mesa | Arizona | United States | |||
| Local Institution |
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| Placebo | Drug | Tablets, Oral, 0 mg, Once daily, 8 weeks. |
|
| La Mesa |
| California |
| United States |
| Local Institution | La Palma | California | United States |
| Local Institution | Long Beach | California | United States |
| Local Institution | Redlands | California | United States |
| Local Institution | San Diego | California | United States |
| Local Institution | Sherman Oaks | California | United States |
| Local Institution | Washington D.C. | District of Columbia | United States |
| Local Institution | Coral Springs | Florida | United States |
| Local Institution | Jacksonville | Florida | United States |
| Local Institution | St. Petersburg | Florida | United States |
| Local Institution | Marietta | Georgia | United States |
| Local Institution | Edwardsville | Illinois | United States |
| Local Institution | Oak Brook | Illinois | United States |
| Local Institution | Springfield | Illinois | United States |
| Local Institution | Lafayette | Indiana | United States |
| Local Institution | Newton | Kansas | United States |
| Local Institution | New Orleans | Louisiana | United States |
| Local Institution | Shreveport | Louisiana | United States |
| Local Institution | Baltimore | Maryland | United States |
| Local Institution | St Louis | Missouri | United States |
| Local Institution | Clementon | New Jersey | United States |
| Local Institution | Albuquerque | New Mexico | United States |
| Local Institution | Brooklyn | New York | United States |
| Local Institution | Elmsford | New York | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Raleigh | North Carolina | United States |
| Local Institution | Dayton | Ohio | United States |
| Local Institution | Media | Pennsylvania | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Pittsburgh | Pennsylvania | United States |
| Local Institution | Columbia | South Carolina | United States |
| Local Institution | DeSoto | Texas | United States |
| Local Institution | Houston | Texas | United States |
| Local Institution | Wichita Falls | Texas | United States |
| Local Institution | Salt Lake City | Utah | United States |
| Local Institution | Charlottesville | Virginia | United States |
| Local Institution | Midlothian | Virginia | United States |
| Local Institution | Bellevue | Washington | United States |
| Local Institution | Charleston | West Virginia | United States |
| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| 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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