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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator |
| |
| A2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who discontinue because of Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments 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 | Hall/Tirol | Austria | ||||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19452380 | Background | 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. |
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| Aripiprazole | Drug | 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. |
|
|
| Vienna |
| Austria |
| Local Institution | Bruges | Belgium |
| Local Institution | Brussels | Belgium |
| Local Institution | Diest | Belgium |
| Local Institution | Halle | Belgium |
| Local Institution | Sint-Denijs-Westrem | Belgium |
| Local Institution | Stokrooie | Belgium |
| Local Institution | Havířov | Czechia |
| Local Institution | Olomouc | Czechia |
| Local Institution | Prague | Czechia |
| Local Institution | Přerov | Czechia |
| Local Institution | Aubagne | France |
| Local Institution | Bordeaux | France |
| Local Institution | Brumath | France |
| Local Institution | Château-Gontier | France |
| Local Institution | Clermont-Ferrand | France |
| Local Institution | Dijon | France |
| Local Institution | Dommartin-lès-Toul | France |
| Local Institution | Fains-Véel | France |
| Local Institution | Hénin-Beaumont | France |
| Local Institution | Le Pecq | France |
| Local Institution | Lyon | France |
| Local Institution | Poitiers | France |
| Local Institution | Reims | France |
| Local Institution | Roubaix | France |
| Local Institution | Toulon | France |
| Local Institution | Toulouse | France |
| Local Institution | Achim | Germany |
| Local Institution | Bochum | Germany |
| Local Institution | Cologne | Germany |
| Local Institution | Ellwangen | Germany |
| Local Institution | Hattingen | Germany |
| Local Institution | Neurnberg | Germany |
| Local Institution | Osnabrück | Germany |
| Local Institution | Ostfildern | Germany |
| Local Institution | Witten | Germany |
| Local Institution | Athens | Greece |
| Local Institution | Chania-Crete | Greece |
| Local Institution | Corfu | Greece |
| Local Institution | Leros | Greece |
| Local Institution | Thessaloniki | Greece |
| Local Institution | Tripoli | Greece |
| Local Institution | Baja | Hungary |
| Local Institution | Eger | Hungary |
| Local Institution | Esztergom | Hungary |
| Local Institution | Kistarcsa | Hungary |
| Local Institution | Pécs | Hungary |
| Local Institution | Sopron | Hungary |
| Local Institution | Sestri Ponente | Genova | Italy |
| Local Institution | Aosta | Italy |
| Local Institution | Bolzano | Italy |
| Local Institution | Foggia | Italy |
| Local Institution | L’Aquila | Italy |
| Local Institution | Milan | Italy |
| Local Institution | Roggiano Gravina (Cs) | Italy |
| Local Institution | Roma | Italy |
| Local Institution | Terrassa | Barcelona | Spain |
| Local Institution | Barcelona | Spain |
| Local Institution | Elche (Alicante) | Spain |
| Local Institution | Langreo-Asturias | Spain |
| Local Institution | Madrid | Spain |
| Local Institution | Murcia | Spain |
| Local Institution | Oviedo | Spain |
| Local Institution | Salamanca | Spain |
| Local Institution | Valencia | Spain |
| Local Institution | Zamora | Spain |
| Local Institution | Newport | Gwent | United Kingdom |
| Local Institution | South Wales | Mid Glamorgan | United Kingdom |
| Local Institution | Hull | North Yorkshire | United Kingdom |
| Local Institution | Dundee | Tayside | United Kingdom |
| Local Institution | Haywards Health | West Sussex | United Kingdom |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic 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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