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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
  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 3

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
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 May 23, 2013