Clinical trial NCT00232687: A Switch Study of BMS-337039 in Schizophrenic Out-patients
Official title: A Comparative, Randomized, Open-Label, Multicenter Study on the Efficacy and Safety of Switch Treatment With Aripiprazole in Schizophrenic Out-patients Who Are Experiencing Insufficient Efficacy With Risperidone and/or Safety and Tolerability Issues, While on Risperidone
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: 2005-10-05
Enrollment: 450
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 clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria
* Out-patients who have been taking Risperidone for minimum 6 weeks who are not optimally controlled and/or experiencing safety/tolerability issues with Risperidone
* Men and women, aged 18 - 65 years

Exclusion Criteria:

* Patients who are at risk for committing suicide
* Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes
* Meeting DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening
* Treatment-resistant to antipsychotic medication

Primary outcomes:
measure: Proportion of patients who discontinue because of Adverse Events
Secondary outcomes:
measure: Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments at endpoint
Other outcomes:
Locations:
city: Hall/Tirol
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Brugge
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Diest
country: Belgium
facility: Local Institution
city: Halle
country: Belgium
facility: Local Institution
city: Sint Denijs Westrem
country: Belgium
facility: Local Institution
city: Stokrooie
country: Belgium
facility: Local Institution
city: Havirov
country: Czech Republic
facility: Local Institution
city: Olomouc
country: Czech Republic
facility: Local Institution
city: Prague 2
country: Czech Republic
facility: Local Institution
city: Prague 8
country: Czech Republic
facility: Local Institution
city: Praha 6
country: Czech Republic
facility: Local Institution
city: Prerov
country: Czech Republic
facility: Local Institution
city: Aubagne
country: France
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Brumath Cedex
country: France
facility: Local Institution
city: Chateau Gontier
country: France
facility: Local Institution
city: Clermont-Ferrand Cedex
country: France
facility: Local Institution
city: Dijon
country: France
facility: Local Institution
city: Dommartin Les Toul
country: France
facility: Local Institution
city: Fains Veel
country: France
facility: Local Institution
city: Henin Beaumont Cedex
country: France
facility: Local Institution
city: Le Pecq
country: France
facility: Local Institution
city: Lyon Cedex 03
country: France
facility: Local Institution
city: Poitiers
country: France
facility: Local Institution
city: Reims Cedex
country: France
facility: Local Institution
city: Roubaix
country: France
facility: Local Institution
city: Toulon
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Achim
country: Germany
facility: Local Institution
city: Bochum
country: Germany
facility: Local Institution
city: Ellwangen
country: Germany
facility: Local Institution
city: Hattingen
country: Germany
facility: Local Institution
city: Koeln
country: Germany
facility: Local Institution
city: Neurnberg
country: Germany
facility: Local Institution
city: Osnabrueck
country: Germany
facility: Local Institution
city: Ostfildern
country: Germany
facility: Local Institution
city: Witten
country: Germany
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Chania-Crete
country: Greece
facility: Local Institution
city: Kerkyra
country: Greece
facility: Local Institution
city: Leros
country: Greece
facility: Local Institution
city: Thessaloniki
country: Greece
facility: Local Institution
city: Tripolis
country: Greece
facility: Local Institution
city: Baja
country: Hungary
facility: Local Institution
city: Eger
country: Hungary
facility: Local Institution
city: Esztergom
country: Hungary
facility: Local Institution
city: Kistarcsa
country: Hungary
facility: Local Institution
city: Pecs
country: Hungary
facility: Local Institution
city: Sopron
country: Hungary
facility: Local Institution
city: Sestri Ponente
country: Italy
facility: Local Institution
state: Genova
city: Aosta
country: Italy
facility: Local Institution
city: Bolzano
country: Italy
facility: Local Institution
city: Foggia
country: Italy
facility: Local Institution
city: L'Aquila
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Roggiano Gravina (Cs)
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Terrassa
country: Spain
facility: Local Institution
state: Barcelona
city: Barcelona
country: Spain
facility: Local Institution
city: Elche (Alicante)
country: Spain
facility: Local Institution
city: Langreo-Asturias
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Murcia
country: Spain
facility: Local Institution
city: Oviedo
country: Spain
facility: Local Institution
city: Salamanca
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Zamora
country: Spain
facility: Local Institution
city: Newport
country: United Kingdom
facility: Local Institution
state: Gwent
city: South Wales
country: United Kingdom
facility: Local Institution
state: Mid Glamorgan
city: Hull
country: United Kingdom
facility: Local Institution
state: North Yorkshire
city: Dundee
country: United Kingdom
facility: Local Institution
state: Tayside
city: Haywards Health
country: United Kingdom
facility: Local Institution
state: West Sussex
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Ryckmans V, Kahn JP, Modell S, Werner C, McQuade RD, Kerselaers W, Lissens J, Sanchez R. Switching to aripiprazole in outpatients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues with risperidone: a randomized, multicentre, open-label study. Pharmacopsychiatry. 2009 May;42(3):114-21. doi: 10.1055/s-0028-1112134. Epub 2009 May 18.