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

Schizophrenia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237939
• Other study ID #: CN138-100
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2005
• Last updated: November 7, 2013
• Start date: September 2002
• Est. completion date: November 2006

Study information

• Verified date: October 2007
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
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
France	Local Institution	Rennes Cedex
Netherlands	Local Institution	Amersfoort
Netherlands	Local Institution	Raalte
Netherlands	Local Institution	Rotterdam
Portugal	Local Institution	Barcelos
Portugal	Local Institution	Ceira
Portugal	Local Institution	Coimbra
Portugal	Local Institution	Lisboa
Portugal	Local Institution	Lisbon
Spain	Local Institution	Barcelona
Spain	Local Institution	Salamanca
Spain	Local Institution	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka America Pharmaceutical

Countries where clinical trial is conducted

Belgium,  France,  Netherlands,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression-Improvement at endpoint
Secondary	Patients' and caregivers' medication preference

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm