Back to resultsSchizophrenia Trial of Aripiprazole
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aripiprazole
Olanzapine or Quetiapine or Risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- Local Institution
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- Local Institution
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- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A1
B1
Arm Description
Outcomes
Primary Outcome Measures
Score on the Investigator Assessment Questionnaire at week 26
Secondary Outcome Measures
Clinical Global Impression scale and patient preference of medication at endpoint
Full Information
NCT ID
NCT00237913
First Posted
October 11, 2005
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00237913
Brief Title
Schizophrenia Trial of Aripiprazole
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
Aripiprazole will show improved effectiveness over the standard of care treatment with one of three atypical antipsychotics (olanzapine, quetiapine and risperidone).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (false)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Active Comparator
Arm Title
B1
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, Oral, 10 - 30 mg, Once daily, 26 weeks.
Intervention Type
Drug
Intervention Name(s)
Olanzapine or Quetiapine or Risperidone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Score on the Investigator Assessment Questionnaire at week 26
Secondary Outcome Measure Information:
Title
Clinical Global Impression scale and patient preference of medication at endpoint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Millet, MD
Organizational Affiliation
Centre Hospitalier Guillaume Régnier, service de Psychiatrie adultes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Local Institution
City
Wien
Country
Austria
Facility Name
Local Institution
City
Prerov
Country
Czech Republic
Facility Name
Local Institution
City
Copenhagen
Country
Denmark
Facility Name
Local Institution
City
Horsholm
Country
Denmark
Facility Name
Local Institution
City
Helsinki
Country
Finland
Facility Name
Local Institution
City
Brumath Cedex
Country
France
Facility Name
Local Institution
City
Dole Cedex
Country
France
Facility Name
Local Institution
City
Henin Beaumont Cedex
Country
France
Facility Name
Local Institution
City
Jonzac Cedex
Country
France
Facility Name
Local Institution
City
Nantes Orvault
Country
France
Facility Name
Local Institution
City
Paris
Country
France
Facility Name
Local Institution
City
Reims Cedex
Country
France
Facility Name
Local Institution
City
Rennes
Country
France
Facility Name
Local Institution
City
Toulouse
Country
France
Facility Name
Local Institution
City
Uzes
Country
France
Facility Name
Local Institution
City
Duisburg
Country
Germany
Facility Name
Local Institution
City
Hattingen
Country
Germany
Facility Name
Local Institution
City
Muenchen
Country
Germany
Facility Name
Local Institution
City
Nuernberg
Country
Germany
Facility Name
Local Institution
City
Oldenburg
Country
Germany
Facility Name
Local Institution
City
Murcia
Country
Spain
Facility Name
Local Institution
City
Bromma
Country
Sweden
Facility Name
Local Institution
City
Gothenburgh
Country
Sweden
Facility Name
Local Institution
City
Halmstad
Country
Sweden
Facility Name
Local Institution
City
Malmo
Country
Sweden
Facility Name
Local Institution
City
Sater
Country
Sweden
Facility Name
Local Institution
City
Belfast
State/Province
Antrim
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
Country
United Kingdom
Facility Name
Local Institution
City
Tunbridge Wells
State/Province
Kent
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
State/Province
Lanarkshire
Country
United Kingdom
Facility Name
Local Institution
City
Davyhulme
State/Province
Lancashire
Country
United Kingdom
Facility Name
Local Institution
City
South Wales
State/Province
Mid Glamorgan
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19102734
Citation
Hanssens L, L'Italien G, Loze JY, Marcus RN, Pans M, Kerselaers W. The effect of antipsychotic medication on sexual function and serum prolactin levels in community-treated schizophrenic patients: results from the Schizophrenia Trial of Aripiprazole (STAR) study (NCT00237913). BMC Psychiatry. 2008 Dec 22;8:95. doi: 10.1186/1471-244X-8-95.
Results Reference
derived
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Schizophrenia Trial of Aripiprazole
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