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The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional therapy to one of the five following medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These medications are already FDA (Food and Drug Administration)-approved treatments for mania.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Licarbazepine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Little Rock | Arkansas | 72201 | United States | ||
| Investigational Site |
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| Orange |
| California |
| 92868 |
| United States |
| Investigational Site | Pico Rivera | California | 90660 | United States |
| Investigational Site | San Diego | California | 92108 | United States |
| Investigational Site | San Diego | California | 92126 | United States |
| Investigational Site | Boca Raton | Florida | 33432 | United States |
| Investigational Site | Atlanta | Georgia | 30308 | United States |
| Investigational Site | Chicago | Illinois | 60640 | United States |
| Investigational Site | Joliet | Illinois | 60435 | United States |
| Investigational Site | Indianapolis | Indiana | 46222 | United States |
| Investigational Site | Topeka | Kansas | 66606 | United States |
| Investigational Site | Kansas City | Missouri | 64133 | United States |
| Investigational Site | St Louis | Missouri | 63104 | United States |
| Invetigational Site | Brooklyne | New York | 11201 | United States |
| Investigational Site | Cedarhurst | New York | 11516 | United States |
| Investigational Site | New York | New York | 10003 | United States |
| Investigational Site | Cincinnati | Ohio | 45267 | United States |
| Investigational Site | Columbus | Ohio | 43210 | United States |
| Investigational Site | Providence | Rhode Island | 02903 | United States |
| Investigational Site | Bellaire | Texas | 77401 | United States |
| Investigational Site | Bellevue | Washington | 98004 | United States |
| Investigational Site | West Allis | Wisconsin | 53227 | United States |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C428744 | 10,11-dihydro-10-hydroxy-5H-dibenz(b,f)azepine-5-carboxamide |
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