Back to resultsA Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
aripiprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A1
A2
Arm Description
Outcomes
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
Full Information
NCT ID
NCT00300846
First Posted
March 8, 2006
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00300846
Brief Title
A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Active Comparator
Arm Title
A2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)
Primary Outcome Measure Information:
Title
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.
Title
The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
Secondary Outcome Measure Information:
Title
Efficacy (PANSS, CGI)
Title
Effectiveness (IAQ, GAF)
Title
Patient Reported Outcomes
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Graz
Country
Austria
Facility Name
Local Institution
City
Innsbruck
Country
Austria
Facility Name
Local Institution
City
Wien
Country
Austria
Facility Name
Local Institution
City
Brno - Bohunice
Country
Czech Republic
Facility Name
Local Institution
City
Hradec Kralove
Country
Czech Republic
Facility Name
Local Institution
City
Litomerice
Country
Czech Republic
Facility Name
Local Institution
City
Opava
Country
Czech Republic
Facility Name
Local Institution
City
Praha
Country
Czech Republic
Facility Name
Local Institution
City
Helsingin Kaupunki
Country
Finland
Facility Name
Local Institution
City
Tampere
Country
Finland
Facility Name
Local Institution
City
Turku
Country
Finland
Facility Name
Local Institution
City
Brumath Cedex
Country
France
Facility Name
Local Institution
City
Bully Les Mines
Country
France
Facility Name
Local Institution
City
Clermont-Ferrand Cedex
Country
France
Facility Name
Local Institution
City
Limoges Cedex
Country
France
Facility Name
Local Institution
City
Lyon Cedex 08
Country
France
Facility Name
Local Institution
City
Nimes
Country
France
Facility Name
Local Institution
City
Paris Cedex 14
Country
France
Facility Name
Local Institution
City
Rennex Cedex 7
Country
France
Facility Name
Local Institution
City
Sotteville Les Rouen
Country
France
Facility Name
Local Institution
City
Augsburg
Country
Germany
Facility Name
Local Institution
City
Berlin
Country
Germany
Facility Name
Local Institution
City
Duisburg
Country
Germany
Facility Name
Local Institution
City
Haar
Country
Germany
Facility Name
Local Institution
City
Heidelberg
Country
Germany
Facility Name
Local Institution
City
Mannheim
Country
Germany
Facility Name
Local Institution
City
Budapest
Country
Hungary
Facility Name
Local Institution
City
Szolnok
Country
Hungary
Facility Name
Local Institution
City
Krakow
Country
Poland
Facility Name
Local Institution
City
Leszno
Country
Poland
Facility Name
Local Institution
City
Skorzewo
Country
Poland
Facility Name
Local Institution
City
Torun
Country
Poland
Facility Name
Local Institution
City
Warszawa
Country
Poland
Facility Name
Local Institution
City
Soweto
State/Province
Gauteng
Country
South Africa
Facility Name
Local Institution
City
Vereeniging
State/Province
Gauteng
Country
South Africa
Facility Name
Local Institution
City
Durban
State/Province
Kwa Zulu Natal
Country
South Africa
Facility Name
Local Institution
City
Bellville
State/Province
Western Cape
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Local Institution
City
Bromma
Country
Sweden
Facility Name
Local Institution
City
Falkoping
Country
Sweden
Facility Name
Local Institution
City
Linkoping
Country
Sweden
Facility Name
Local Institution
City
Lulea
Country
Sweden
Facility Name
Local Institution
City
Malmo
Country
Sweden
Facility Name
Local Institution
City
Solna
Country
Sweden
Facility Name
Local Institution
City
Uppsala
Country
Sweden
Facility Name
Local Institution
City
Varberg
Country
Sweden
Facility Name
Local Institution
City
Vastra Frolunda
Country
Sweden
Facility Name
Local Institution
City
Bern 60
Country
Switzerland
Facility Name
Local Institution
City
Antalya
Country
Turkey
Facility Name
Local Institution
City
Istanbul
Country
Turkey
Facility Name
Local Institution
City
Izmir
Country
Turkey
Facility Name
Local Institution
City
Exeter
State/Province
Devon
Country
United Kingdom
Facility Name
Local Institution
City
Teignmouth
State/Province
Devon
Country
United Kingdom
Facility Name
Local Institution
City
Welwyn Garden City
State/Province
Hertfordshire
Country
United Kingdom
Facility Name
Local Institution
City
Hull
State/Province
North Yorkshire
Country
United Kingdom
Facility Name
Local Institution
City
Dundee
State/Province
Tayside
Country
United Kingdom
Facility Name
Local Institution
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
20459883
Citation
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.
Results Reference
derived
Learn more about this trial
A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients
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