Broad Effectiveness: Study With Aripiprazole

This study has been completed.

First Received: May 8, 2002 Last Updated: June 27, 2008 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:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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

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

Study ID Numbers:	CN138-087
Study First Received:	May 8, 2002
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00036361 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia

Mental Disorders
Therapeutic Uses
Psychotic Disorders
Aripiprazole
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 05, 2009