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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator |
| |
| A2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aripiprazole | Drug | Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine. | ||
| The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (PANSS, CGI) | ||
| Effectiveness (IAQ, GAF) | ||
| Patient Reported Outcomes |
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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 | Graz | Austria | ||||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20459883 | Derived | Fleischhacker WW, Heikkinen ME, Olie JP, Landsberg W, Dewaele P, McQuade RD, Loze JY, Hennicken D, Kerselaers W. Effects of adjunctive treatment with aripiprazole on body weight and clinical efficacy in schizophrenia patients treated with clozapine: a randomized, double-blind, placebo-controlled trial. Int J Neuropsychopharmacol. 2010 Sep;13(8):1115-25. doi: 10.1017/S1461145710000490. Epub 2010 May 12. |
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| Placebo | Drug | Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional) |
|
| Safety |
| Innsbruck |
| Austria |
| Local Institution | Vienna | Austria |
| Local Institution | Brno-Bohunice | Czechia |
| Local Institution | Hradec Králové | Czechia |
| Local Institution | Litoměřice | Czechia |
| Local Institution | Opava | Czechia |
| Local Institution | Prague | Czechia |
| Local Institution | Helsingin Kaupunki | Finland |
| Local Institution | Tampere | Finland |
| Local Institution | Turku | Finland |
| Local Institution | Brumath | France |
| Local Institution | Bully-les-Mines | France |
| Local Institution | Clermont-Ferrand | France |
| Local Institution | Limoges | France |
| Local Institution | Lyon | France |
| Local Institution | Nîmes | France |
| Local Institution | Paris | France |
| Local Institution | Rennex Cedex 7 | France |
| Local Institution | Sotteville-lès-Rouen | France |
| Local Institution | Augsburg | Germany |
| Local Institution | Berlin | Germany |
| Local Institution | Duisburg | Germany |
| Local Institution | Haar | Germany |
| Local Institution | Heidelberg | Germany |
| Local Institution | Mannheim | Germany |
| Local Institution | Budapest | Hungary |
| Local Institution | Szolnok | Hungary |
| Local Institution | Krakow | Poland |
| Local Institution | Leszno | Poland |
| Local Institution | Skorzewo | Poland |
| Local Institution | Torun | Poland |
| Local Institution | Warsaw | Poland |
| Local Institution | Soweto | Gauteng | South Africa |
| Local Institution | Vereeniging | Gauteng | South Africa |
| Local Institution | Durban | KwaZulu-Natal | South Africa |
| Local Institution | Bellville | Western Cape | South Africa |
| Local Institution | Cape Town | Western Cape | South Africa |
| Local Institution | Bromma | Sweden |
| Local Institution | Falköping | Sweden |
| Local Institution | Linköping | Sweden |
| Local Institution | Luleå | Sweden |
| Local Institution | Malmö | Sweden |
| Local Institution | Solna | Sweden |
| Local Institution | Uppsala | Sweden |
| Local Institution | Varberg | Sweden |
| Local Institution | Västra Frölunda | Sweden |
| Local Institution | Bern | Switzerland |
| Local Institution | Antalya | Turkey (Türkiye) |
| Local Institution | Istanbul | Turkey (Türkiye) |
| Local Institution | Izmir | Turkey (Türkiye) |
| Local Institution | Exeter | Devon | United Kingdom |
| Local Institution | Teignmouth | Devon | United Kingdom |
| Local Institution | Welwyn Garden City | Hertfordshire | United Kingdom |
| Local Institution | Hull | North Yorkshire | United Kingdom |
| Local Institution | Dundee | Tayside | United Kingdom |
| Local Institution | London | 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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