A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237939
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : November 8, 2013
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices (Broad Effectiveness Trial With Aripiprazole- BETA)
Study Start Date : September 2002
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Primary Outcome Measures :
  1. Clinical Global Impression-Improvement at endpoint

Secondary Outcome Measures :
  1. Patients' and caregivers' medication preference

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical DSM-IV diagnosis of schizophrenia
  • Patients being managed as outpatients, for whom an alteration in medication is clinically reasonable or initiation of antipsychotics is required

Exclusion Criteria:

  • Risk of committing suicide, diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic syptoms, or organic brain syndromes
  • Prisoners or subjects compulsory detained

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237939

Local Institution
Antwerpen, Belgium
Local Institution
Bruxelles, Belgium
Local Institution
Diest, Belgium
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Kortenberg, Belgium
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Liege, Belgium
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Sint-Michiels, Belgium
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Sint-Niklaas, Belgium
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Sint-Truiden, Belgium
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Tournai, Belgium
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Rennes Cedex, France
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Amersfoort, Netherlands
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Raalte, Netherlands
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Rotterdam, Netherlands
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Barcelos, Portugal
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Ceira, Portugal
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Coimbra, Portugal
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Lisboa, Portugal
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Lisbon, Portugal
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Barcelona, Spain
Local Institution
Salamanca, Spain
Local Institution
Sevilla, Spain
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Principal Investigator: Hervé Allain, MD Faculté de Médecine de Rennes I, laboratoire de pharmacologie

Additional Information: Identifier: NCT00237939     History of Changes
Other Study ID Numbers: CN138-100
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: October 2007

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs