Study of Aripiprazole in Patients With a History of Bipolar Disorder - Full Text View

Purpose

The purpose of this study is to learn if aripiprazole is effective in the treatment of patients with a history of bipolar disorder.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Aripiprazole	Phase 3

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Study Start Date:	March 2000
Study Completion Date:	June 2003
Primary Completion Date:	June 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

Patients with a history of Bipolar I Disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036348

Locations

United States, Alabama
Local Institution
Birmingham, Alabama, United States
Local Institution
Tuscaloosa, Alabama, United States
United States, California
Local Institution
Chillicothe, California, United States
Local Institution
Riverside, California, United States
Local Institution
Stanford, California, United States
Local Institution
Torrance, California, United States
United States, Georgia
Local Institution
Atlanta, Georgia, United States
United States, Illinois
Local Institution
Chicago, Illinois, United States
United States, Kentucky
Local Institution
Louisville, Kentucky, United States
United States, Louisiana
Local Institution
Shreveport, Louisiana, United States
United States, Massachusetts
Local Institution
Belmont, Massachusetts, United States
United States, Nevada
Local Institution
Las Vegas, Nevada, United States
United States, New Mexico
Local Institution
Albuquerque, New Mexico, United States
United States, New York
Local Institution
New York, New York, United States
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States
United States, Tennessee
Local Institution
Memphis, Tennessee, United States
Local Institution
Nashville, Tennessee, United States
United States, Texas
Local Institution
Austin, Texas, United States
Local Institution
San Antonio, Texas, United States

Sponsors and Collaborators

Bristol-Myers Squibb

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 Bristol-Myers Squibb

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

Kemp DE, Calabrese JR, Tran QV, Pikalov A, Eudicone JM, Baker RA. Metabolic syndrome in patients enrolled in a clinical trial of aripiprazole in the maintenance treatment of bipolar I disorder: a post hoc analysis of a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2010 Sep;71(9):1138-44. Epub 2010 May 4.

Muzina DJ, Momah C, Eudicone JM, Pikalov A, McQuade RD, Marcus RN, Sanchez R, Carlson BX. Aripiprazole monotherapy in patients with rapid-cycling bipolar I disorder: an analysis from a long-term, double-blind, placebo-controlled study. Int J Clin Pract. 2008 May;62(5):679-87. Epub 2008 Mar 25.

Keck PE Jr, Calabrese JR, McIntyre RS, McQuade RD, Carson WH, Eudicone JM, Carlson BX, Marcus RN, Sanchez R; Aripiprazole Study Group. Aripiprazole monotherapy for maintenance therapy in bipolar I disorder: a 100-week, double-blind study versus placebo. J Clin Psychiatry. 2007 Oct;68(10):1480-91.

ClinicalTrials.gov Identifier:	NCT00036348 History of Changes
Other Study ID Numbers:	CN138-010
Study First Received:	May 8, 2002
Last Updated:	April 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Bipolar I disorder

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
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 16, 2013