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
| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|
| Change on a depression rating scale at endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate and Clinical Global Impression scale at endpoint |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Tuscaloosa | Alabama | United States | |||
| Local Institution |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Tablets, Oral, 0 mg, Once daily, 8 weeks. |
|
| Little Rock |
| Arkansas |
| United States |
| Local Institution | San Diego | California | United States |
| Local Institution | Sherman Oaks | California | United States |
| Local Institution | Norwich | Connecticut | United States |
| Local Institution | West Haven | Connecticut | United States |
| Local Institution | Jacksonville | Florida | United States |
| Local Institution | Maitland | Florida | United States |
| Local Institution | Orlando | Florida | United States |
| Local Insstitution | Honolulu | Hawaii | United States |
| Local Institution | Chicago | Illinois | United States |
| Local Institution | Lake Charles | Louisiana | United States |
| Local Institution | Rockville | Maryland | United States |
| Local Institution | Durham | North Carolina | United States |
| Local Institution | Raleigh | North Carolina | United States |
| Local Institution | Beachwood | Ohio | United States |
| Local Institution | Dayton | Ohio | United States |
| Local Institution | Oklahoma City | Oklahoma | United States |
| Local Institution | Portland | Oregon | United States |
| Local Institution | Media | Pennsylvania | United States |
| Local Institution | Memphis | Tennessee | United States |
| Local Institution | Austin | Texas | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | Houston | Texas | United States |
| Local Institution | Lake Jackson | Texas | United States |
| Local Institution | Wichita Falls | Texas | United States |
| Local Institution | Arlington | Virginia | United States |
| Local Institution | Bellevue | Washington | United States |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003244 | Consciousness Disorders |
| 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 |
| D019965 | Neurocognitive Disorders |
Not provided
Not provided
| 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 |
Not provided
Not provided