A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients
NCT ID: NCT00300846
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
200 participants
INTERVENTIONAL
2005-12-31
2007-07-31
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
DOUBLE
Study Groups
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A1
aripiprazole
Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
A2
Placebo
Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)
Interventions
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aripiprazole
Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
Placebo
Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hospitalized patients
* Patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.
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
Graz, , Austria
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Innsbruck, , Austria
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Vienna, , Austria
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Brno - Bohunice, , Czechia
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Hradec Králové, , Czechia
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Litoměřice, , Czechia
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Opava, , Czechia
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Prague, , Czechia
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Helsingin Kaupunki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Brumath, , France
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Bully-les-Mines, , France
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Clermont-Ferrand, , France
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Limoges, , France
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Lyon, , France
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Nîmes, , France
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Paris, , France
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Rennex Cedex 7, , France
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Sotteville-lès-Rouen, , France
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Augsburg, , Germany
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Berlin, , Germany
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Duisburg, , Germany
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Haar, , Germany
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Heidelberg, , Germany
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Mannheim, , Germany
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Budapest, , Hungary
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Szolnok, , Hungary
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Krakow, , Poland
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Leszno, , Poland
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Skorzewo, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Soweto, Gauteng, South Africa
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Vereeniging, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Bellville, Western Cape, South Africa
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Cape Town, Western Cape, South Africa
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Bromma, , Sweden
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Falköping, , Sweden
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Linköping, , Sweden
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Luleå, , Sweden
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Malmo, , Sweden
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Solna, , Sweden
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Uppsala, , Sweden
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Varberg, , Sweden
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Västra Frölunda, , Sweden
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Bern, , Switzerland
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Antalya, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Exeter, Devon, United Kingdom
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Teignmouth, Devon, United Kingdom
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Welwyn Garden City, Hertfordshire, United Kingdom
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Hull, North Yorkshire, United Kingdom
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Dundee, Tayside, United Kingdom
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London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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CN138-170
Identifier Type: -
Identifier Source: org_study_id