Schizophrenia Trial of Aripiprazole

Schizophrenia Clinical Trial

Official title:

A Multicenter, Randomized, Naturalistic, Open-Label Study Between Aripiprazole and Standard of Care in the Management of Community-Treated Schizophrenic Patients (Schizophrenia Trial of Aripiprazole - STAR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237913
• Other study ID #: CN138-152
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2005
• Last updated: November 7, 2013
• Start date: July 2004
• Est. completion date: August 2005

Study information

• Verified date: July 2008
• 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
• Study type: Interventional

Clinical Trial Summary

Aripiprazole will show improved effectiveness over the standard of care treatment with one of three atypical antipsychotics (olanzapine, quetiapine and risperidone).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of schizophrenia

• Schizophrenia symptoms not optimally controlled or antipsychotic medication not well tolerated

Exclusion Criteria:

• Diagnosis of schizoaffective disorder

• Patients treatment-resistant to antipsychotics

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
Tablets, Oral, 10 - 30 mg, Once daily, 26 weeks.
• Olanzapine or Quetiapine or Risperidone
Olanzapine: Tablets, Oral, 5-20 mg, Once daily, 26 weeks. OR Quetiapine: Tablets, Oral, 100-800 mg, Once daily, 26 weeks. OR Risperidone: Tablets, Oral, 2-8 mg, Once daily, 26 weeks.

Locations

Country	Name	City	State
Austria	Local Institution	Wien
Czech Republic	Local Institution	Prerov
Denmark	Local Institution	Copenhagen
Denmark	Local Institution	Horsholm
Finland	Local Institution	Helsinki
France	Local Institution	Brumath Cedex
France	Local Institution	Dole Cedex
France	Local Institution	Henin Beaumont Cedex
France	Local Institution	Jonzac Cedex
France	Local Institution	Nantes Orvault
France	Local Institution	Paris
France	Local Institution	Reims Cedex
France	Local Institution	Rennes
France	Local Institution	Toulouse
France	Local Institution	Uzes
Germany	Local Institution	Duisburg
Germany	Local Institution	Hattingen
Germany	Local Institution	Muenchen
Germany	Local Institution	Nuernberg
Germany	Local Institution	Oldenburg
Spain	Local Institution	Murcia
Sweden	Local Institution	Bromma
Sweden	Local Institution	Gothenburgh
Sweden	Local Institution	Halmstad
Sweden	Local Institution	Malmo
Sweden	Local Institution	Sater
United Kingdom	Local Institution	Belfast	Antrim
United Kingdom	Local Institution	Birmingham	West Midlands
United Kingdom	Local Institution	Davyhulme	Lancashire
United Kingdom	Local Institution	Glasgow	Lanarkshire
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	South Wales	Mid Glamorgan
United Kingdom	Local Institution	Tunbridge Wells	Kent

Sponsors (2)

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

Countries where clinical trial is conducted

Austria,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Investigator Assessment Questionnaire at week 26
Secondary	Clinical Global Impression scale and patient preference of medication at endpoint

External Links

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