Broad Effectiveness: Study With Aripiprazole

This study has been completed.

Sponsor:

Collaborator:

Otsuka America Pharmaceutical

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00036361

First received: May 8, 2002

Last updated: September 10, 2010

Last verified: September 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	May 8, 2002
Last Updated Date	September 10, 2010
Start Date ^ICMJE	July 2002
Primary Completion Date	January 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 9, 2005)	Safety Assessments
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00036361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 9, 2005)	Safety Assessments
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Broad Effectiveness: Study With Aripiprazole
Official Title ^ICMJE	Broad Effectiveness: Study With Aripiprazole
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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Schizophrenia Schizoaffective Disorder
Intervention ^ICMJE	Drug: Aripiprazole
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	444
Completion Date	January 2003
Primary Completion Date	January 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Patients with Schizophrenia or Schizoaffective Disorder
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00036361
Other Study ID Numbers ^ICMJE	CN138-087
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Otsuka America Pharmaceutical
Investigators ^ICMJE	Not Provided
Information Provided By	Bristol-Myers Squibb
Verification Date	September 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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