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

November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Hall/Tirol, Austria
        • Local Institution
      • Wien, Austria
        • Local Institution
  • Belgium
      • Brugge, Belgium
        • Local Institution
      • Bruxelles, Belgium
        • Local Institution
      • Diest, Belgium
        • Local Institution
      • Halle, Belgium
        • Local Institution
      • Sint Denijs Westrem, Belgium
        • Local Institution
      • Stokrooie, Belgium
        • Local Institution
  • Czech Republic
      • 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, Czech Republic
        • Local Institution
  • France
      • 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, France
        • Local Institution
  • Germany
      • 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, Germany
        • Local Institution
  • Greece
      • Athens, Greece
        • Local Institution
      • Chania-Crete, Greece
        • Local Institution
      • Kerkyra, Greece
        • Local Institution
      • Leros, Greece
        • Local Institution
      • Thessaloniki, Greece
        • Local Institution
      • Tripolis, Greece
        • Local Institution
  • Hungary
      • Baja, Hungary
        • Local Institution
      • Eger, Hungary
        • Local Institution
      • Esztergom, Hungary
        • Local Institution
      • Kistarcsa, Hungary
        • Local Institution
      • Pecs, Hungary
        • Local Institution
      • Sopron, Hungary
        • Local Institution
  • Italy
      • 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
    • Genova
      • Sestri Ponente, Genova, Italy
        • Local Institution
  • Spain
      • 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
    • Barcelona
      • Terrassa, Barcelona, Spain
        • Local Institution
  • United Kingdom
    • Gwent
      • Newport, Gwent, United Kingdom
        • Local Institution
    • Mid Glamorgan
      • South Wales, Mid Glamorgan, United Kingdom
        • Local Institution
    • North Yorkshire
      • Hull, North Yorkshire, United Kingdom
        • Local Institution
    • Tayside
      • Dundee, Tayside, United Kingdom
        • Local Institution
    • West Sussex
      • Haywards Health, West Sussex, United Kingdom
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A1
Drug: Aripiprazole
Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
Other Names:
  • Abilify
Drug: 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.
Other Names:
  • Abilify
Active Comparator: A2
Drug: Aripiprazole
Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
Other Names:
  • Abilify
Drug: 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.
Other Names:
  • Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of patients who discontinue because of Adverse Events

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka America Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

October 3, 2005

First Submitted That Met QC Criteria

October 3, 2005

First Posted (Estimate)

October 5, 2005

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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