Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 treatment with either lithium or valproate, which are already FDA (Food and Drug Administration)-approved treatments for mania.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| licarbazepine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Licarbazepine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6). |
| Measure | Description | Time Frame |
|---|---|---|
| Major improvement in anxiety and depression from baseline to endpoint (week 6) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | La Palma | California | 90623 | United States | ||
| Investigational Site |
Not provided
| Label | URL |
|---|---|
| Click here for further information and to find an investigational site near you | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Kansas City |
| Kansas |
| 66160 |
| United States |
| Investigational Site | Shreveport | Louisiana | 71101 | United States |
| Investigational Site | Somerville | Massachusetts | 02143 | United States |
| Investigational Site | Farmington Hills | Michigan | 48334 | United States |
| Investigational Site | Staten Island | New York | 10305 | United States |
| Investigational Site | Madison | Tennessee | 37115 | United States |
| Investigational Site | Bellaire | Texas | 77401 | United States |
| Investigational Site | Dallas | Texas | 75235 | United States |
| Investigational Site | Bellevue | Washington | 98004 | United States |
| Investigational Site | Kirkland | Washington | 98033 | United States |
| Investigational Site | West Allis | Wisconsin | 53227 | United States |
| Novartis Investigational Site | Vienna | Austria |
| Novartis investigator site | Greater Sudbury | Canada |
| Novartis Investigational Site | Kelowna | Canada |
| Novartis investigator site | London | Canada |
| Novartis investigator site | Montreal | Canada |
| Novartis investigator site | Vancouver | Canada |
| Novartis investigator site | Verdun | Canada |
| Guatemala | Bogotá | Colombia |
| Guatemala | Medellín | Colombia |
| Guatemala | Pareira | Colombia |
| Novartis Investigational Site | Brno | Czechia |
| Novartis Investigational Site | Hradec Králové | Czechia |
| Novartis Investigational Site | Prague | Czechia |
| Novartis Investigational Site | Berlin | Germany |
| Novartis Investigational Site | Bochum | Germany |
| Novartis Investigational Site | Dresden | Germany |
| Novartis Investigational Site | Ingolstadt | Germany |
| Novartis Investigational Site | Mannheim | Germany |
| Novartis Investigational Site | Würzburg | Germany |
| Novartis Investigational Site | Guatemala City | Guatemala |
| Novartis Investigational Site | Lima | Peru |
| Novartis Investigational Site | Moscow | Russia |
| Novartis Investigational Site | Yaroslavl | Russia |
| Novartis Investigational Site | Bojnice | Slovakia |
| Novartis Investigational Site | Michalovce | Slovakia |
| Novartis Investigational Site | Durban | South Africa |
| Novartis Investigational Site | Dnipro | Ukraine |
| Novartis Investigational Site | Kiev | Ukraine |
| Novartis Investigational Site | Luhansk | Ukraine |
| Novartis Investigational Site | Odesa | Ukraine |
| Novartis Investigational Site | Simferopol | Ukraine |
| Novartis Investigational Site | Caracas | Venezuela |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C428744 | 10,11-dihydro-10-hydroxy-5H-dibenz(b,f)azepine-5-carboxamide |
Not provided
Not provided
Not provided