NCT00095511

Brief Summary

The purpose of this trial is to test the safety \& efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
615

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2004

Typical duration for phase_3

Geographic Reach
1 country

38 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

June 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2004

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

November 11, 2013

Status Verified

May 1, 2008

Enrollment Period

2.9 years

First QC Date

November 5, 2004

Last Update Submit

November 7, 2013

Conditions

Bipolar Disorder

Keywords

Bipolar Mania

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to endpoint in a mania rating scale

Secondary Outcomes (1)

  • Response rate and Clinical Global Impression scale at endpoint

Interventions

aripiprazoleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis of Acute Bipolar I Mania

You may not qualify if:

  • Patients with a DSM-IV diagnosis other than Bipolar I Mania

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Local Institution

Tuscaloosa, Alabama, United States

Location

Local Institution

Scottsdale, Arizona, United States

Location

Local Institution

Cerritos, California, United States

Location

Local Institution

Garden Grove, California, United States

Location

Local Institution

La Palma, California, United States

Location

Local Institution

Riverside, California, United States

Location

Local Institution

San Diego, California, United States

Location

Local Institution

Denver, Colorado, United States

Location

Local Institution

Middletown, Connecticut, United States

Location

Local Institution

New Haven, Connecticut, United States

Location

Local Institution

Bradenton, Florida, United States

Location

Local Institution

Kissimmee, Florida, United States

Location

Local Institution

Maitland, Florida, United States

Location

Local Institution

Augusta, Georgia, United States

Location

Local Institution

Honolulu, Hawaii, United States

Location

Local Institution

Chicago, Illinois, United States

Location

Local Institution

Hoffman Estates, Illinois, United States

Location

Local Institution

Indianapolis, Indiana, United States

Location

Local Institution

Louisville, Kentucky, United States

Location

Local Institution

New Orleans, Louisiana, United States

Location

Local Institition

Shreveport, Louisiana, United States

Location

Local Institution

Saint Charles, Missouri, United States

Location

Local Institution

Clementon, New Jersey, United States

Location

Local Institution

Cedarhurst, New York, United States

Location

Local Institution

Elmsford, New York, United States

Location

Local Institution

Holliswood, New York, United States

Location

Local Institution

Morganton, North Carolina, United States

Location

Local Institution

Raleigh, North Carolina, United States

Location

Local Institution

Cincinnati, Ohio, United States

Location

Local Institution

Cleveland, Ohio, United States

Location

Local Institution

Lyndhurst, Ohio, United States

Location

Local Institution

Oklahoma City, Oklahoma, United States

Location

Local Institution

Norristown, Pennsylvania, United States

Location

Local Institution

Philadelphia, Pennsylvania, United States

Location

Local Institution

Austin, Texas, United States

Location

Local Institution

Bellaire, Texas, United States

Location

Local Institution

Houston, Texas, United States

Location

Local Institution

Arlington, Virginia, United States

Location

Related Publications (2)

  • Keck PE, Orsulak PJ, Cutler AJ, Sanchez R, Torbeyns A, Marcus RN, McQuade RD, Carson WH; CN138-135 Study Group. Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, double-blind, placebo- and lithium-controlled study. J Affect Disord. 2009 Jan;112(1-3):36-49. doi: 10.1016/j.jad.2008.05.014. Epub 2008 Oct 2.

    PMID: 18835043BACKGROUND

  • McIntyre RS, McElroy SL, Eudicone JM, Forbes RA, Carlson BX, Baker RA. A 52-week, double-blind evaluation of the metabolic effects of aripiprazole and lithium in bipolar I disorder. Prim Care Companion CNS Disord. 2011;13(6):PCC.11m01182. doi: 10.4088/PCC.11m01182.

    PMID: 22454801DERIVED

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 Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 5, 2004

First Posted

November 8, 2004

Study Start

June 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

November 11, 2013

Record last verified: 2008-05

Locations

US(38)