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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Aripiprazole
Aripiprazole
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A1

A2

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients who discontinue because of Adverse Events

Secondary Outcome Measures

Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments at endpoint

Full Information

First Posted
October 3, 2005
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00232687
Brief Title
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

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Active Comparator
Arm Title
A2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients who discontinue because of Adverse Events
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments at endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Hall/Tirol
Country
Austria
Facility Name
Local Institution
City
Wien
Country
Austria
Facility Name
Local Institution
City
Brugge
Country
Belgium
Facility Name
Local Institution
City
Bruxelles
Country
Belgium
Facility Name
Local Institution
City
Diest
Country
Belgium
Facility Name
Local Institution
City
Halle
Country
Belgium
Facility Name
Local Institution
City
Sint Denijs Westrem
Country
Belgium
Facility Name
Local Institution
City
Stokrooie
Country
Belgium
Facility Name
Local Institution
City
Havirov
Country
Czech Republic
Facility Name
Local Institution
City
Olomouc
Country
Czech Republic
Facility Name
Local Institution
City
Prague 2
Country
Czech Republic
Facility Name
Local Institution
City
Prague 8
Country
Czech Republic
Facility Name
Local Institution
City
Praha 6
Country
Czech Republic
Facility Name
Local Institution
City
Prerov
Country
Czech Republic
Facility Name
Local Institution
City
Aubagne
Country
France
Facility Name
Local Institution
City
Bordeaux
Country
France
Facility Name
Local Institution
City
Brumath Cedex
Country
France
Facility Name
Local Institution
City
Chateau Gontier
Country
France
Facility Name
Local Institution
City
Clermont-Ferrand Cedex
Country
France
Facility Name
Local Institution
City
Dijon
Country
France
Facility Name
Local Institution
City
Dommartin Les Toul
Country
France
Facility Name
Local Institution
City
Fains Veel
Country
France
Facility Name
Local Institution
City
Henin Beaumont Cedex
Country
France
Facility Name
Local Institution
City
Le Pecq
Country
France
Facility Name
Local Institution
City
Lyon Cedex 03
Country
France
Facility Name
Local Institution
City
Poitiers
Country
France
Facility Name
Local Institution
City
Reims Cedex
Country
France
Facility Name
Local Institution
City
Roubaix
Country
France
Facility Name
Local Institution
City
Toulon
Country
France
Facility Name
Local Institution
City
Toulouse
Country
France
Facility Name
Local Institution
City
Achim
Country
Germany
Facility Name
Local Institution
City
Bochum
Country
Germany
Facility Name
Local Institution
City
Ellwangen
Country
Germany
Facility Name
Local Institution
City
Hattingen
Country
Germany
Facility Name
Local Institution
City
Koeln
Country
Germany
Facility Name
Local Institution
City
Neurnberg
Country
Germany
Facility Name
Local Institution
City
Osnabrueck
Country
Germany
Facility Name
Local Institution
City
Ostfildern
Country
Germany
Facility Name
Local Institution
City
Witten
Country
Germany
Facility Name
Local Institution
City
Athens
Country
Greece
Facility Name
Local Institution
City
Chania-Crete
Country
Greece
Facility Name
Local Institution
City
Kerkyra
Country
Greece
Facility Name
Local Institution
City
Leros
Country
Greece
Facility Name
Local Institution
City
Thessaloniki
Country
Greece
Facility Name
Local Institution
City
Tripolis
Country
Greece
Facility Name
Local Institution
City
Baja
Country
Hungary
Facility Name
Local Institution
City
Eger
Country
Hungary
Facility Name
Local Institution
City
Esztergom
Country
Hungary
Facility Name
Local Institution
City
Kistarcsa
Country
Hungary
Facility Name
Local Institution
City
Pecs
Country
Hungary
Facility Name
Local Institution
City
Sopron
Country
Hungary
Facility Name
Local Institution
City
Sestri Ponente
State/Province
Genova
Country
Italy
Facility Name
Local Institution
City
Aosta
Country
Italy
Facility Name
Local Institution
City
Bolzano
Country
Italy
Facility Name
Local Institution
City
Foggia
Country
Italy
Facility Name
Local Institution
City
L'Aquila
Country
Italy
Facility Name
Local Institution
City
Milano
Country
Italy
Facility Name
Local Institution
City
Roggiano Gravina (Cs)
Country
Italy
Facility Name
Local Institution
City
Roma
Country
Italy
Facility Name
Local Institution
City
Terrassa
State/Province
Barcelona
Country
Spain
Facility Name
Local Institution
City
Barcelona
Country
Spain
Facility Name
Local Institution
City
Elche (Alicante)
Country
Spain
Facility Name
Local Institution
City
Langreo-Asturias
Country
Spain
Facility Name
Local Institution
City
Madrid
Country
Spain
Facility Name
Local Institution
City
Murcia
Country
Spain
Facility Name
Local Institution
City
Oviedo
Country
Spain
Facility Name
Local Institution
City
Salamanca
Country
Spain
Facility Name
Local Institution
City
Valencia
Country
Spain
Facility Name
Local Institution
City
Zamora
Country
Spain
Facility Name
Local Institution
City
Newport
State/Province
Gwent
Country
United Kingdom
Facility Name
Local Institution
City
South Wales
State/Province
Mid Glamorgan
Country
United Kingdom
Facility Name
Local Institution
City
Hull
State/Province
North Yorkshire
Country
United Kingdom
Facility Name
Local Institution
City
Dundee
State/Province
Tayside
Country
United Kingdom
Facility Name
Local Institution
City
Haywards Health
State/Province
West Sussex
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19452380
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.
Results Reference
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Learn more about this trial

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

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