Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders

This study has been completed.

Sponsor:

Information provided by:

Otsuka Pharmaceutical Development & Commercialization, Inc.

ClinicalTrials.gov Identifier:

NCT00036127

First received: May 7, 2002

Last updated: November 7, 2013

Last verified: September 2007

History of Changes

Purpose

Study to learn if the alternate formulation is effective in agitated schizophrenic patients

Condition	Intervention	Phase
Schizophrenia	Drug: aripiprazole	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:


Study Start Date:	April 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 and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Agitated schizophrenic patients

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036127

Locations


United States, California
Local Institution
Anaheim, California, United States
Local Institution
Cerritos, California, United States
Local Institution
Chula Vista, California, United States
Local Institution
Rosemead, California, United States
Local Institution
San Diego, California, United States
United States, Georgia
Local Institution
Atlanta, Georgia, United States
Local Institution
Macon, Georgia, United States
United States, Illinois
Local Instituton
Hoffman Estates, Illinois, United States
United States, Nevada
Local Institution
Las Vegas, Nevada, United States
United States, New Hampshire
Local Institution
Nashua, New Hampshire, United States
United States, New York
Local Institution
New York, New York, United States
United States, Ohio
Local Institution
Beachwood, Ohio, United States
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States
United States, South Carolina
Local Institution
Charleston, South Carolina, United States
United States, Texas
Local Institution
Houston, Texas, United States
United States, Wisconsin
Local Institution
Milwaukee, Wisconsin, United States

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

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 by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tran-Johnson TK, Sack DA, Marcus RN, Auby P, McQuade RD, Oren DA. Efficacy and safety of intramuscular aripiprazole in patients with acute agitation: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2007 Jan;68(1):111-9.


ClinicalTrials.gov Identifier:	NCT00036127 History of Changes
Other Study ID Numbers:	CN138-050
Study First Received:	May 7, 2002
Last Updated:	November 7, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:


agitated schizophrenic patients

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 27, 2015

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