NCT00036348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2000

Typical duration for phase_3

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

November 11, 2013

Status Verified

September 1, 2007

Enrollment Period

3.3 years

First QC Date

May 8, 2002

Last Update Submit

November 7, 2013

Conditions

Keywords

Bipolar I disorder

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Patients with a history of Bipolar I Disorder

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (19)

Local Institution

Birmingham, Alabama, United States

Location

Local Institution

Tuscaloosa, Alabama, United States

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Local Institution

Chillicothe, California, United States

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Local Institution

Riverside, California, United States

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Local Institution

Stanford, California, United States

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Local Institution

Torrance, California, United States

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Local Institution

Atlanta, Georgia, United States

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Local Institution

Chicago, Illinois, United States

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Local Institution

Louisville, Kentucky, United States

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Local Institution

Shreveport, Louisiana, United States

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Local Institution

Belmont, Massachusetts, United States

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Local Institution

Las Vegas, Nevada, United States

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Local Institution

Albuquerque, New Mexico, United States

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Local Institution

New York, New York, United States

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Local Institution

Philadelphia, Pennsylvania, United States

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Local Institution

Memphis, Tennessee, United States

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Local Institution

Nashville, Tennessee, United States

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Local Institution

Austin, Texas, United States

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Local Institution

San Antonio, Texas, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 8, 2002

First Posted

May 10, 2002

Study Start

March 1, 2000

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

November 11, 2013

Record last verified: 2007-09

Locations