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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.
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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 | Little Rock | Arkansas | United States | |||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18381903 | Background | Vieta E, T'joen C, McQuade RD, Carson WH Jr, Marcus RN, Sanchez R, Owen R, Nameche L. Efficacy of adjunctive aripiprazole to either valproate or lithium in bipolar mania patients partially nonresponsive to valproate/lithium monotherapy: a placebo-controlled study. Am J Psychiatry. 2008 Oct;165(10):1316-25. doi: 10.1176/appi.ajp.2008.07101560. Epub 2008 Apr 1. | |
| 20429835 |
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| Riverside |
| California |
| United States |
| Local Institution | Deerfield Beach | Florida | United States |
| Local Institution | Jacksonville | Florida | United States |
| Local Institution | Maitland | Florida | United States |
| Local Institution | Hoffman Estates | Illinois | United States |
| Local Institution | Oak Brook | Illinois | United States |
| Local Institution | Newton | Kansas | United States |
| Local Institution | Newton | Massachusetts | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Staten Island | New York | United States |
| Local Institution | Raleigh | North Carolina | United States |
| Local Institution | Dayton | Ohio | United States |
| Local Institution | Media | Pennsylvania | United States |
| Local Institution | Norristown | Pennsylvania | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Columbia | South Carolina | United States |
| Local Institution | Memphis | Tennessee | United States |
| Local Institution | Austin | Texas | United States |
| Local Institution | Bellevue | Washington | United States |
| Local Institution | Epping | Victoria | Australia |
| Local Institution | Rousse | Bulgaria |
| Local Institution | Sofia | Bulgaria |
| Local Institution | Varna | Bulgaria |
| Local Institution | Brno-Bohunice | Czechia |
| Local Institution | Hradec Králové | Czechia |
| Local Institution | Opava | Czechia |
| Local Institution | Prague | Czechia |
| Local Institution | Pärnu | Estonia |
| Local Institution | Tallinn | Estonia |
| Local Institution | Tartu | Estonia |
| Local Institution | Viljandi Maakond | Estonia |
| Local Institution | Voru Maakond | Estonia |
| Local Institution | Bordeaux | France |
| Local Institution | Dole | France |
| Local Institution | Grenoble | France |
| Local Institution | Jonzac | France |
| Local Institution | La Rochelle | France |
| Local Institution | Limoges | France |
| Local Institution | Marseille | France |
| Local Institution | Nîmes | France |
| Local Institution | Pessac | France |
| Local Institution | Rennes | France |
| Local Institution | Berlin | Germany |
| Local Institution | Jena | Germany |
| Local Institution | Magdeburg | Germany |
| Local Institution | Meunchen | Germany |
| Local Institution | Westersted | Germany |
| Local Institution | Budapest | Hungary |
| Local Institution | Gyula | Hungary |
| Local Institution | Kecskemét | Hungary |
| Local Institution | Nagykálló | Hungary |
| Local Institution | Bassano del Grappa | Italy |
| Local Institution | Cagliari | Italy |
| Local Institution | Florence | Italy |
| Local Institution | Pisa | Italy |
| Local Institution | Roma | Italy |
| Local Institution | Sassari | Italy |
| Local Institution | Trieste | Italy |
| Local Institution | Voghera -Pavia | Italy |
| Local Institution | Retranchement | Netherlands |
| Local Institution | Zaandam | Netherlands |
| Local Institution | Choroszcz | Poland |
| Local Institution | Kościan | Poland |
| Local Institution | Krakow | Poland |
| Local Institution | Poznan | Poland |
| Local Institution | Torun | Poland |
| Local Institution | Tuszyn | Poland |
| Local Institution | Lisbon | Portugal |
| Local Institution | Leningrad Region | Russia |
| Local Institution | Moscow | Russia |
| Local Institution | Saint Petersburg | Russia |
| Local Institution | Smolensk | Russia |
| Local Institution | Port Elizabeth | Eastern Cape | South Africa |
| Local Institution | Westdene | Free State | South Africa |
| Local Institution | Pretoria | Gauteng | South Africa |
| Local Institution | Vereeniging | Gauteng | South Africa |
| Local Institution | Welkom | Gauteng | South Africa |
| Local Institution | Durban | KwaZulu-Natal | South Africa |
| Local Institution | Observatory | Western Cape | South Africa |
| Local Institution | Barcelona | Spain |
| Local Institution | Madrid | Spain |
| Local Institution | Valencia | Spain |
| Local Institution | Vitoria-Gasteiz | Spain |
| Local Institution | Herisau | Switzerland |
| Local Institution | Glasgow | Dumbartonshire | United Kingdom |
| Local Institution | London | Greater London | United Kingdom |
| Local Institution | Burnley | Lancashire | United Kingdom |
| Local Institution | South Wales | Mid Glamorgan | United Kingdom |
| Local Institution | Surbiton | Middlesex | United Kingdom |
| Vieta E, Owen R, Baudelet C, McQuade RD, Sanchez R, Marcus RN. Assessment of safety, tolerability and effectiveness of adjunctive aripiprazole to lithium/valproate in bipolar mania: a 46-week, open-label extension following a 6-week double-blind study. Curr Med Res Opin. 2010 Jun;26(6):1485-96. doi: 10.1185/03007991003779380. |
| 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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