Broad Effectiveness: Study With Aripiprazole
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Patients with Schizophrenia or Schizoaffective Disorder
Sites / Locations
- Local Institution
Outcomes
Primary Outcome Measures
Safety Assessments
Secondary Outcome Measures
Safety Assessments
Full Information
NCT ID
NCT00036361
First Posted
May 8, 2002
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00036361
Brief Title
Broad Effectiveness: Study With Aripiprazole
Official Title
Broad Effectiveness: Study With Aripiprazole
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (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 study is to learn if aripiprazole is effective in the treatment of a large number of persons diagnosed with schizophrenia or schizoaffective disorders
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
444 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Primary Outcome Measure Information:
Title
Safety Assessments
Secondary Outcome Measure Information:
Title
Safety Assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with Schizophrenia or Schizoaffective Disorder
Facility Information:
Facility Name
Local Institution
City
Wallingford
State/Province
Connecticut
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Broad Effectiveness: Study With Aripiprazole
We'll reach out to this number within 24 hrs