Broad Effectiveness: Study With Aripiprazole

This study has been completed.

First Received on May 8, 2002. Last Updated on September 10, 2010 History of Changes

Sponsor:	Bristol-Myers Squibb
Collaborator:	Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00036361

Purpose

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

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Aripiprazole	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Broad Effectiveness: Study With Aripiprazole

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Safety Assessments

Secondary Outcome Measures:

Safety Assessments

Estimated Enrollment:	444
Study Start Date:	July 2002
Study Completion Date:	January 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients with Schizophrenia or Schizoaffective Disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036361

Locations

United States, Connecticut
Local Institution
Wallingford, Connecticut, United States

Sponsors and Collaborators

Bristol-Myers Squibb

Otsuka America Pharmaceutical

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00036361 History of Changes
Other Study ID Numbers:	CN138-087
Study First Received:	May 8, 2002
Last Updated:	September 10, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012