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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator |
| |
| B | Experimental |
| |
| C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in a mania rating scale at endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate and Clinical Global Impression scale at 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 | Anaheim | California | United States | |||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19118324 | Background | Young AH, Oren DA, Lowy A, McQuade RD, Marcus RN, Carson WH, Spiller NH, Torbeyns AF, Sanchez R. Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study. Br J Psychiatry. 2009 Jan;194(1):40-8. doi: 10.1192/bjp.bp.108.049965. |
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| Aripiprazole | Drug | Tablets, oral, 15-30 mg, once daily, 12 weeks. |
|
|
| Haloperidol | Drug | Capsule, oral, 5-15 mg, once daily, 12 weeks. |
|
| Cerritos |
| California |
| United States |
| Local Institution | Garden Grove | California | United States |
| Local Institution | National City | California | United States |
| Local Institution | Pico Rivera | California | United States |
| Local Institution | Riverside | California | United States |
| Local Institution | San Diego | California | United States |
| Local Institution | Washington D.C. | District of Columbia | United States |
| Local Institution | Maitland | Florida | United States |
| Local Institution | Tampa | Florida | United States |
| Local Institution | Shreveport | Louisiana | United States |
| Local Institution | Albuquerque | New Mexico | United States |
| Local Institution | Cleveland | Ohio | United States |
| Local Institution | Oklahoma City | Oklahoma | United States |
| Local Institution | DeSoto | Texas | United States |
| Local Institution | Burgas | Bulgaria |
| Local Institution | Novi Iskar | Bulgaria |
| Local Institution | Pleven | Bulgaria |
| Local Institution | Sofia | Bulgaria |
| Local Institution | Varna | Bulgaria |
| Local Institution | Osijek | Croatia |
| Local Institution | Rijeka | Croatia |
| Local Institution | Split | Croatia |
| Local Institution | Zagreb | Croatia |
| Local Institution | Zapopan | Jalisco | Mexico |
| Local Institution | Mexico City | Mexico City | Mexico |
| Local Institution | Col. Obispado | Nuevo León | Mexico |
| Local Institution | Monterrey | Nuevo León | Mexico |
| Local Institution | Fracc. Industrias | San Luis Potosí | Mexico |
| Local Institution | Mérida | Yucatán | Mexico |
| Local Institution | Nuevo León | Mexico |
| Local Institution | Lima | Lima Province | Peru |
| Local Institution | Lipetsk | Lipetsk Oblast | Russia |
| Local Institution | Arkhangelsk | Russia |
| Local Institution | Kazan' | Russia |
| Local Institution | Leningrad Region | Russia |
| Local Institution | Moscow | Russia |
| Local Institution | Nizhny Novgorod | Russia |
| Local Institution | Saint Petersburg | Russia |
| Local Institution | Samara | Russia |
| Local Institution | Volgograd | Russia |
| Local Institution | Florida | Gauteng | South Africa |
| Local Institution | Pretoria | Gauteng | South Africa |
| Local Institution | Berea | Kwa Zuluu Natal | South Africa |
| Local Institution | Durban | KwaZulu-Natal | South Africa |
| 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 |
| D006220 | Haloperidol |
| 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 |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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