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Study of Aripiprazole in Patients With a History of Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar I disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patients with a history of Bipolar I Disorder

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 8, 2002
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00036348
Brief Title
Study of Aripiprazole in Patients With a History of Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar I disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aripiprazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with a history of Bipolar I Disorder
Facility Information:
Facility Name
Local Institution
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Local Institution
City
Tuscaloosa
State/Province
Alabama
Country
United States
Facility Name
Local Institution
City
Chillicothe
State/Province
California
Country
United States
Facility Name
Local Institution
City
Riverside
State/Province
California
Country
United States
Facility Name
Local Institution
City
Stanford
State/Province
California
Country
United States
Facility Name
Local Institution
City
Torrance
State/Province
California
Country
United States
Facility Name
Local Institution
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Local Institution
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Local Institution
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Local Institution
City
Belmont
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Local Institution
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Local Institution
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Local Institution
City
Austin
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20492838
Citation
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. doi: 10.4088/JCP.09m05159gre. Epub 2010 May 4.
Results Reference
derived
PubMed Identifier
18373615
Citation
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. doi: 10.1111/j.1742-1241.2008.01735.x. Epub 2008 Mar 25.
Results Reference
derived
PubMed Identifier
17960961
Citation
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. doi: 10.4088/jcp.v68n1003.
Results Reference
derived

Learn more about this trial

Study of Aripiprazole in Patients With a History of Bipolar Disorder

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