Study of Aripiprazole in Patients With Bipolar I Disorder
NCT ID: NCT00257972
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2004-10-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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aripiprazole
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
* Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole
18 Years
ALL
No
Sponsors
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Otsuka America Pharmaceutical
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Surbiton, Middlesex, United Kingdom
Local Institution
Little Rock, Arkansas, United States
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Riverside, California, United States
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Deerfield Beach, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Hoffman Estates, Illinois, United States
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Oak Brook, Illinois, United States
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Newton, Kansas, United States
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Newton, Massachusetts, United States
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New York, New York, United States
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Staten Island, New York, United States
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Raleigh, North Carolina, United States
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Dayton, Ohio, United States
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Media, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Bellevue, Washington, United States
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Epping, Victoria, Australia
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Brno - Bohunice, , Czechia
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Hradec Králové, , Czechia
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Opava, , Czechia
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Prague, , Czechia
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Pärnu, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Viljandi Maakond, , Estonia
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Voru Maakond, , Estonia
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Bordeaux, , France
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Dole, , France
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Grenoble, , France
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Jonzac, , France
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La Rochelle, , France
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Limoges, , France
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Marseille, , France
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Nîmes, , France
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Pessac, , France
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Rennes, , France
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Berlin, , Germany
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Jena, , Germany
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Magdeburg, , Germany
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Meunchen, , Germany
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Westersted, , Germany
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Budapest, , Hungary
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Gyula, , Hungary
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Kecskemét, , Hungary
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Nagykálló, , Hungary
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Bassano del Grappa, , Italy
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Cagliari, , Italy
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Florence, , Italy
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Pisa, , Italy
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Roma, , Italy
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Sassari, , Italy
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Trieste, , Italy
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Voghera -Pavia, , Italy
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Retranchement, , Netherlands
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Zaandam, , Netherlands
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Choroszcz, , Poland
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Kościan, , Poland
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Krakow, , Poland
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Poznan, , Poland
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Torun, , Poland
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Tuszyn, , Poland
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Lisbon, , Portugal
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Leningrad Region, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Port Elizabeth, Eastern Cape, South Africa
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Westdene, Free State, South Africa
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Pretoria, Gauteng, South Africa
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Vereeniging, Gauteng, South Africa
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Welkom, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Observatory, Western Cape, South Africa
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Barcelona, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Vitoria-Gasteiz, , Spain
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Herisau, , Switzerland
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Glasgow, Dumbartonshire, United Kingdom
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London, Greater London, United Kingdom
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Burnley, Lancashire, United Kingdom
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South Wales, Mid Glamorgan, United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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CN138-134
Identifier Type: -
Identifier Source: org_study_id