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

This study has been completed.

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00237939

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 III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Bristol-Myers Squibb:

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

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

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
Raalte, Netherlands
Local Institution
Amersfoort, Netherlands
Local Institution
Rotterdam, Netherlands
Portugal
Local Institution
Coimbra, Portugal
Local Institution
Ceira, Portugal
Local Institution
Lisbon, Portugal
Local Institution
Lisboa, Portugal
Local Institution
Barcelos, Portugal
Spain
Local Institution
Barcelona, Spain
Local Institution
Sevilla, Spain
Local Institution
Barcelona, Spain
Local Institution
Salamanca, Spain
Local Institution
Barcelona, Spain

Sponsors and Collaborators

Bristol-Myers Squibb

Otsuka America Pharmaceutical

Investigators

Principal Investigator:

Hervé Allain, MD

Faculté de Médecine de Rennes I, laboratoire de pharmacologie

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	CN138-100
Study First Received:	October 11, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00237939
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Aripiprazole
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009