A Switch Study of BMS-337039 in Schizophrenic Out-patients
NCT ID: NCT00232687
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
PHASE4
450 participants
INTERVENTIONAL
2005-06-30
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A1
Aripiprazole
Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
A2
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Out-patients who have been taking Risperidone for minimum 6 weeks who are not optimally controlled and/or experiencing safety/tolerability issues with Risperidone
* Men and women, aged 18 - 65 years
Exclusion Criteria
* Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes
* Meeting DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening
* Treatment-resistant to antipsychotic medication
18 Years
65 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
Hall/Tirol, , Austria
Local Institution
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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Neurnberg, , 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-Crete, , Greece
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Corfu, , Greece
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Leros, , 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 (Cs), , 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 (Alicante), , Spain
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Langreo-Asturias, , 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
Local Institution
Haywards Health, West Sussex, United Kingdom
Countries
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References
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Ryckmans V, Kahn JP, Modell S, Werner C, McQuade RD, Kerselaers W, Lissens J, Sanchez R. Switching to aripiprazole in outpatients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues with risperidone: a randomized, multicentre, open-label study. Pharmacopsychiatry. 2009 May;42(3):114-21. doi: 10.1055/s-0028-1112134. Epub 2009 May 18.
Other Identifiers
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CN138-169
Identifier Type: -
Identifier Source: org_study_id