A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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
Sites / Locations
- Local Institution
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Outcomes
Primary Outcome Measures
Clinical Global Impression-Improvement at endpoint
Secondary Outcome Measures
Patients' and caregivers' medication preference
Full Information
NCT ID
NCT00237939
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
NCT00237939
Brief Title
A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
4. Oversight
5. Study Description
Brief 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.
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
1200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Primary Outcome Measure Information:
Title
Clinical Global Impression-Improvement at endpoint
Secondary Outcome Measure Information:
Title
Patients' and caregivers' medication preference
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hervé Allain, MD
Organizational Affiliation
Faculté de Médecine de Rennes I, laboratoire de pharmacologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Local Institution
City
Antwerpen
Country
Belgium
Facility Name
Local Institution
City
Bruxelles
Country
Belgium
Facility Name
Local Institution
City
Diest
Country
Belgium
Facility Name
Local Institution
City
Kortenberg
Country
Belgium
Facility Name
Local Institution
City
Liege
Country
Belgium
Facility Name
Local Institution
City
Sint-Michiels
Country
Belgium
Facility Name
Local Institution
City
Sint-Niklaas
Country
Belgium
Facility Name
Local Institution
City
Sint-Truiden
Country
Belgium
Facility Name
Local Institution
City
Tournai
Country
Belgium
Facility Name
Local Institution
City
Rennes Cedex
Country
France
Facility Name
Local Institution
City
Amersfoort
Country
Netherlands
Facility Name
Local Institution
City
Raalte
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
Country
Netherlands
Facility Name
Local Institution
City
Barcelos
Country
Portugal
Facility Name
Local Institution
City
Ceira
Country
Portugal
Facility Name
Local Institution
City
Coimbra
Country
Portugal
Facility Name
Local Institution
City
Lisboa
Country
Portugal
Facility Name
Local Institution
City
Lisbon
Country
Portugal
Facility Name
Local Institution
City
Barcelona
Country
Spain
Facility Name
Local Institution
City
Salamanca
Country
Spain
Facility Name
Local Institution
City
Sevilla
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices
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