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A Switch Study of BMS-337039 in Schizophrenic Out-patients
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone.
Official title: A Comparative, Randomized, Open-Label, Multicenter Study on the Efficacy and Safety of Switch Treatment With Aripiprazole in Schizophrenic Out-patients Who Are Experiencing Insufficient Efficacy With Risperidone and/or Safety and Tolerability Issues, While on Risperidone
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2005-06-01
Completion Date
2007-04-01
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
Aripiprazole
Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
Aripiprazole
Tablets, Oral, Uptitration: 5 mg (week 1), 10 mg (week 2 and 3), 15 mg(week 4 and 5) flexible 10-30mg from week 6-12, once daily, 12 weeks.
Locations (72)
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Hall in Tirol, Austria
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Vienna, Austria
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Bruges, Belgium
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Brussels, Belgium
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Diest, Belgium
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Halle, Belgium
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Sint-Denijs-Westrem, Belgium
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Stokrooie, Belgium
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Havířov, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Přerov, Czechia
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Aubagne, France
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Bordeaux, France
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Brumath, France
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Château-Gontier, France
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Clermont-Ferrand, France
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Dijon, France
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Dommartin-lès-Toul, France
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Fains-Véel, France
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Hénin-Beaumont, France
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Le Pecq, France
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Lyon, France
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Poitiers, France
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Reims, France
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Roubaix, France
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Toulon, France
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Toulouse, France
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Achim, Germany
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Bochum, Germany
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Cologne, Germany
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Ellwangen, Germany
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Hattingen, Germany
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Nuremberg, Germany
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Osnabrück, Germany
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Ostfildern, Germany
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Witten, Germany
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Athens, Greece
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Chania, Greece
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Corfu, Greece
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Kalymnos, Greece
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Thessaloniki, Greece
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Tripoli, Greece
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Baja, Hungary
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Eger, Hungary
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Esztergom, Hungary
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Kistarcsa, Hungary
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Pécs, Hungary
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Sopron, Hungary
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Sestri Ponente, Genova, Italy
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Aosta, Italy
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Bolzano, Italy
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Foggia, Italy
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L’Aquila, Italy
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Milan, Italy
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Roggiano Gravina, Italy
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Roma, Italy
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Terrassa, Barcelona, Spain
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Barcelona, Spain
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Elche, Spain
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Langreo, Spain
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Madrid, Spain
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Murcia, Spain
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Oviedo, Spain
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Salamanca, Spain
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Valencia, Spain
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Zamora, Spain
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Newport, Gwent, United Kingdom
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South Wales, Mid Glamorgan, United Kingdom
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Hull, North Yorkshire, United Kingdom
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Dundee, Tayside, United Kingdom
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Haywards Heath, West Sussex, United Kingdom