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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
The purpose of this trial is to test the safety & efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aripiprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in a mania rating scale |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate and Clinical Global Impression scale at endpoint |
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Inclusion Criteria:
Exclusion 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 | Tuscaloosa | Alabama | United States | |||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18835043 | Background | Keck PE, Orsulak PJ, Cutler AJ, Sanchez R, Torbeyns A, Marcus RN, McQuade RD, Carson WH; CN138-135 Study Group. Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, double-blind, placebo- and lithium-controlled study. J Affect Disord. 2009 Jan;112(1-3):36-49. doi: 10.1016/j.jad.2008.05.014. Epub 2008 Oct 2. | |
| 22454801 |
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| Scottsdale |
| Arizona |
| United States |
| Local Institution | Cerritos | California | United States |
| Local Institution | Garden Grove | California | United States |
| Local Institution | La Palma | California | United States |
| Local Institution | Riverside | California | United States |
| Local Institution | San Diego | California | United States |
| Local Institution | Denver | Colorado | United States |
| Local Institution | Middletown | Connecticut | United States |
| Local Institution | New Haven | Connecticut | United States |
| Local Institution | Bradenton | Florida | United States |
| Local Institution | Kissimmee | Florida | United States |
| Local Institution | Maitland | Florida | United States |
| Local Institution | Augusta | Georgia | United States |
| Local Institution | Honolulu | Hawaii | United States |
| Local Institution | Chicago | Illinois | United States |
| Local Institution | Hoffman Estates | Illinois | United States |
| Local Institution | Indianapolis | Indiana | United States |
| Local Institution | Louisville | Kentucky | United States |
| Local Institution | New Orleans | Louisiana | United States |
| Local Institition | Shreveport | Louisiana | United States |
| Local Institution | Saint Charles | Missouri | United States |
| Local Institution | Clementon | New Jersey | United States |
| Local Institution | Cedarhurst | New York | United States |
| Local Institution | Elmsford | New York | United States |
| Local Institution | Holliswood | New York | United States |
| Local Institution | Morganton | North Carolina | United States |
| Local Institution | Raleigh | North Carolina | United States |
| Local Institution | Cincinnati | Ohio | United States |
| Local Institution | Cleveland | Ohio | United States |
| Local Institution | Lyndhurst | Ohio | United States |
| Local Institution | Oklahoma City | Oklahoma | United States |
| Local Institution | Norristown | Pennsylvania | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Austin | Texas | United States |
| Local Institution | Bellaire | Texas | United States |
| Local Institution | Houston | Texas | United States |
| Local Institution | Arlington | Virginia | United States |
| McIntyre RS, McElroy SL, Eudicone JM, Forbes RA, Carlson BX, Baker RA. A 52-week, double-blind evaluation of the metabolic effects of aripiprazole and lithium in bipolar I disorder. Prim Care Companion CNS Disord. 2011;13(6):PCC.11m01182. doi: 10.4088/PCC.11m01182. |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood 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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