A Switch Study of BMS-337039 in Schizophrenic Out-patients

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232687
• Other study ID #: CN138-169
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2005
• Last updated: November 7, 2013
• Start date: June 2005
• Est. completion date: April 2007

Study information

• Verified date: February 2012
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne Alimentaire et Environnement
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole
Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
• Aripiprazole
Tablets, Oral, Uptitration: 5 mg (week 1), 10 mg (week 2 and 3), 15 mg(week 4 and 5) flexible 10-30mg from week 6-12, once daily, 12 weeks.

Locations

Country	Name	City	State
Austria	Local Institution	Hall/Tirol
Austria	Local Institution	Wien
Belgium	Local Institution	Brugge
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	Diest
Belgium	Local Institution	Halle
Belgium	Local Institution	Sint Denijs Westrem
Belgium	Local Institution	Stokrooie
Czech Republic	Local Institution	Havirov
Czech Republic	Local Institution	Olomouc
Czech Republic	Local Institution	Prague 2
Czech Republic	Local Institution	Prague 8
Czech Republic	Local Institution	Praha 6
Czech Republic	Local Institution	Prerov
France	Local Institution	Aubagne
France	Local Institution	Bordeaux
France	Local Institution	Brumath Cedex
France	Local Institution	Chateau Gontier
France	Local Institution	Clermont-Ferrand Cedex
France	Local Institution	Dijon
France	Local Institution	Dommartin Les Toul
France	Local Institution	Fains Veel
France	Local Institution	Henin Beaumont Cedex
France	Local Institution	Le Pecq
France	Local Institution	Lyon Cedex 03
France	Local Institution	Poitiers
France	Local Institution	Reims Cedex
France	Local Institution	Roubaix
France	Local Institution	Toulon
France	Local Institution	Toulouse
Germany	Local Institution	Achim
Germany	Local Institution	Bochum
Germany	Local Institution	Ellwangen
Germany	Local Institution	Hattingen
Germany	Local Institution	Koeln
Germany	Local Institution	Neurnberg
Germany	Local Institution	Osnabrueck
Germany	Local Institution	Ostfildern
Germany	Local Institution	Witten
Greece	Local Institution	Athens
Greece	Local Institution	Chania-Crete
Greece	Local Institution	Kerkyra
Greece	Local Institution	Leros
Greece	Local Institution	Thessaloniki
Greece	Local Institution	Tripolis
Hungary	Local Institution	Baja
Hungary	Local Institution	Eger
Hungary	Local Institution	Esztergom
Hungary	Local Institution	Kistarcsa
Hungary	Local Institution	Pecs
Hungary	Local Institution	Sopron
Italy	Local Institution	Aosta
Italy	Local Institution	Bolzano
Italy	Local Institution	Foggia
Italy	Local Institution	L'Aquila
Italy	Local Institution	Milano
Italy	Local Institution	Roggiano Gravina (Cs)
Italy	Local Institution	Roma
Italy	Local Institution	Sestri Ponente	Genova
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	Terrassa	Barcelona
Spain	Local Institution	Valencia
Spain	Local Institution	Zamora
United Kingdom	Local Institution	Dundee	Tayside
United Kingdom	Local Institution	Haywards Health	West Sussex
United Kingdom	Local Institution	Hull	North Yorkshire
United Kingdom	Local Institution	Newport	Gwent
United Kingdom	Local Institution	South Wales	Mid Glamorgan

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka America Pharmaceutical

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  France,  Germany,  Greece,  Hungary,  Italy,  Spain,  United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who discontinue because of Adverse Events
Secondary	Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments at endpoint

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm