A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients
A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.
1 other identifier
interventional
200
12 countries
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started Dec 2005
Shorter than P25 for phase_4 schizophrenia
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 8, 2006
CompletedFirst Posted
Study publicly available on registry
March 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedNovember 8, 2013
June 1, 2008
1.6 years
March 8, 2006
November 7, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Efficacy (PANSS, CGI)
Effectiveness (IAQ, GAF)
Patient Reported Outcomes
Safety
Study Arms (2)
A1
ACTIVE COMPARATORA2
PLACEBO COMPARATORInterventions
Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)
Eligibility Criteria
You may qualify if:
- Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Local Institution
Graz, Austria
Local Institution
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
Malmo, 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
Related Publications (1)
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.
PMID: 20459883DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 8, 2006
First Posted
March 10, 2006
Study Start
December 1, 2005
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
November 8, 2013
Record last verified: 2008-06