We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00237939
First Posted: October 13, 2005
Last Update Posted: November 8, 2013
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.
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
  Purpose
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 Intervention Phase
Schizophrenia Drug: Aripiprazole Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Clinical Global Impression-Improvement at endpoint

Secondary Outcome Measures:
  • Patients' and caregivers' medication preference

Estimated Enrollment: 1200
Study Start Date: September 2002
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00237939


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00237939     History of Changes
Other Study ID Numbers: CN138-100
First Submitted: October 11, 2005
First Posted: October 13, 2005
Last Update Posted: November 8, 2013
Last Verified: October 2007

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