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

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00237939
First received: October 11, 2005
Last updated: November 7, 2013
Last verified: October 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00237939     History of Changes
Other Study ID Numbers: CN138-100
Study First Received: October 11, 2005
Last Updated: November 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014