A Switch Study of BMS-337039 in Schizophrenic Out-patients
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
1 other identifier
interventional
450
10 countries
72
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.
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 Jun 2005
72 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
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 3, 2005
CompletedFirst Posted
Study publicly available on registry
October 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedNovember 8, 2013
February 1, 2012
1.8 years
October 3, 2005
November 7, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients who discontinue because of Adverse Events
Secondary Outcomes (1)
Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments at endpoint
Study Arms (2)
A1
ACTIVE COMPARATORA2
ACTIVE COMPARATORInterventions
Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Local Institution
Hall/Tirol, Austria
Local Institution
Vienna, Austria
Local Institution
Bruges, Belgium
Local Institution
Brussels, Belgium
Local Institution
Diest, Belgium
Local Institution
Halle, Belgium
Local Institution
Sint-Denijs-Westrem, Belgium
Local Institution
Stokrooie, Belgium
Local Institution
Havířov, Czechia
Local Institution
Olomouc, Czechia
Local Institution
Prague, Czechia
Local Institution
Přerov, Czechia
Local Institution
Aubagne, France
Local Institution
Bordeaux, France
Local Institution
Brumath, France
Local Institution
Château-Gontier, France
Local Institution
Clermont-Ferrand, France
Local Institution
Dijon, France
Local Institution
Dommartin-lès-Toul, France
Local Institution
Fains-Véel, France
Local Institution
Hénin-Beaumont, France
Local Institution
Le Pecq, France
Local Institution
Lyon, France
Local Institution
Poitiers, France
Local Institution
Reims, France
Local Institution
Roubaix, France
Local Institution
Toulon, France
Local Institution
Toulouse, France
Local Institution
Achim, Germany
Local Institution
Bochum, Germany
Local Institution
Cologne, Germany
Local Institution
Ellwangen, Germany
Local Institution
Hattingen, Germany
Local Institution
Neurnberg, Germany
Local Institution
Osnabrück, Germany
Local Institution
Ostfildern, Germany
Local Institution
Witten, Germany
Local Institution
Athens, Greece
Local Institution
Chania-Crete, Greece
Local Institution
Corfu, Greece
Local Institution
Leros, Greece
Local Institution
Thessaloniki, Greece
Local Institution
Tripoli, Greece
Local Institution
Baja, Hungary
Local Institution
Eger, Hungary
Local Institution
Esztergom, Hungary
Local Institution
Kistarcsa, Hungary
Local Institution
Pécs, Hungary
Local Institution
Sopron, Hungary
Local Institution
Sestri Ponente, Genova, Italy
Local Institution
Aosta, Italy
Local Institution
Bolzano, Italy
Local Institution
Foggia, Italy
Local Institution
L’Aquila, Italy
Local Institution
Milan, Italy
Local Institution
Roggiano Gravina (Cs), Italy
Local Institution
Roma, Italy
Local Institution
Terrassa, Barcelona, Spain
Local Institution
Barcelona, Spain
Local Institution
Elche (Alicante), Spain
Local Institution
Langreo-Asturias, Spain
Local Institution
Madrid, Spain
Local Institution
Murcia, Spain
Local Institution
Oviedo, Spain
Local Institution
Salamanca, Spain
Local Institution
Valencia, Spain
Local Institution
Zamora, Spain
Local Institution
Newport, Gwent, United Kingdom
Local Institution
South Wales, Mid Glamorgan, United Kingdom
Local Institution
Hull, North Yorkshire, United Kingdom
Local Institution
Dundee, Tayside, United Kingdom
Local Institution
Haywards Health, West Sussex, United Kingdom
Related Publications (1)
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.
PMID: 19452380BACKGROUND
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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 3, 2005
First Posted
October 5, 2005
Study Start
June 1, 2005
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
November 8, 2013
Record last verified: 2012-02