Clinical trial NCT00300846: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2006-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
measure: The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
Secondary outcomes:
measure: Efficacy (PANSS, CGI)
measure: Effectiveness (IAQ, GAF)
measure: Patient Reported Outcomes
measure: Safety
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Local Institution
city: Innsbruck
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Brno - Bohunice
country: Czech Republic
facility: Local Institution
city: Hradec Kralove
country: Czech Republic
facility: Local Institution
city: Litomerice
country: Czech Republic
facility: Local Institution
city: Opava
country: Czech Republic
facility: Local Institution
city: Praha
country: Czech Republic
facility: Local Institution
city: Helsingin Kaupunki
country: Finland
facility: Local Institution
city: Tampere
country: Finland
facility: Local Institution
city: Turku
country: Finland
facility: Local Institution
city: Brumath Cedex
country: France
facility: Local Institution
city: Bully Les Mines
country: France
facility: Local Institution
city: Clermont-Ferrand Cedex
country: France
facility: Local Institution
city: Limoges Cedex
country: France
facility: Local Institution
city: Lyon Cedex 08
country: France
facility: Local Institution
city: Nimes
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Rennex Cedex 7
country: France
facility: Local Institution
city: Sotteville Les Rouen
country: France
facility: Local Institution
city: Augsburg
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Duisburg
country: Germany
facility: Local Institution
city: Haar
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Szolnok
country: Hungary
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Leszno
country: Poland
facility: Local Institution
city: Skorzewo
country: Poland
facility: Local Institution
city: Torun
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Soweto
country: South Africa
facility: Local Institution
state: Gauteng
city: Vereeniging
country: South Africa
facility: Local Institution
state: Gauteng
city: Durban
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Bellville
country: South Africa
facility: Local Institution
state: Western Cape
city: Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Bromma
country: Sweden
facility: Local Institution
city: Falkoping
country: Sweden
facility: Local Institution
city: Linkoping
country: Sweden
facility: Local Institution
city: Lulea
country: Sweden
facility: Local Institution
city: Malmo
country: Sweden
facility: Local Institution
city: Solna
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
city: Varberg
country: Sweden
facility: Local Institution
city: Vastra Frolunda
country: Sweden
facility: Local Institution
city: Bern 60
country: Switzerland
facility: Local Institution
city: Antalya
country: Turkey
facility: Local Institution
city: Istanbul
country: Turkey
facility: Local Institution
city: Izmir
country: Turkey
facility: Local Institution
city: Exeter
country: United Kingdom
facility: Local Institution
state: Devon
city: Teignmouth
country: United Kingdom
facility: Local Institution
state: Devon
city: Welwyn Garden City
country: United Kingdom
facility: Local Institution
state: Hertfordshire
city: Hull
country: United Kingdom
facility: Local Institution
state: North Yorkshire
city: Dundee
country: United Kingdom
facility: Local Institution
state: Tayside
city: London
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.