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A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients

This study has been completed.
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: March 8, 2006
Last updated: November 7, 2013
Last verified: June 2008
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.

Condition Intervention Phase
Drug: aripiprazole
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.

Resource links provided by NLM:

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Efficacy (PANSS, CGI)
  • Effectiveness (IAQ, GAF)
  • Patient Reported Outcomes
  • Safety

Estimated Enrollment: 200
Study Start Date: December 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1 Drug: aripiprazole
Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
Other Name: Abilify
Placebo Comparator: A2 Drug: Placebo
Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine.

Exclusion Criteria:

  • Patients known to be allergic to aripiprazole
  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00300846

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Graz, Austria
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Innsbruck, Austria
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Wien, Austria
Czech Republic
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Brno - Bohunice, Czech Republic
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Hradec Kralove, Czech Republic
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Litomerice, Czech Republic
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Opava, Czech Republic
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Praha, Czech Republic
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Helsingin Kaupunki, Finland
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Tampere, Finland
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Turku, Finland
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Brumath Cedex, France
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Bully Les Mines, France
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Clermont-Ferrand Cedex, France
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Limoges Cedex, France
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Lyon Cedex 08, France
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Nimes, France
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Paris Cedex 14, France
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Rennex Cedex 7, France
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Sotteville Les 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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Warszawa, Poland
South Africa
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Soweto, Gauteng, South Africa
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Vereeniging, Gauteng, South Africa
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Durban, Kwa Zulu 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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Falkoping, Sweden
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Linkoping, Sweden
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Lulea, 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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Vastra Frolunda, Sweden
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Bern 60, Switzerland
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Antalya, Turkey
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Istanbul, Turkey
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Izmir, Turkey
United Kingdom
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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
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00300846     History of Changes
Other Study ID Numbers: CN138-170
Study First Received: March 8, 2006
Last Updated: November 7, 2013

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on April 26, 2017