NCT00097266

Brief Summary

The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.

Trial Health

93
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 Dec 2004

Geographic Reach
7 countries

45 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

First Submitted

Initial submission to the registry

November 19, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2004

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

November 8, 2013

Status Verified

July 1, 2010

Enrollment Period

2.1 years

First QC Date

November 19, 2004

Last Update Submit

November 7, 2013

Conditions

Bipolar Disorder

Keywords

Bipolar Mania

Outcome Measures

Primary Outcomes (1)

  • Change in a mania rating scale at endpoint

Secondary Outcomes (1)

  • Response rate and Clinical Global Impression scale at endpoint

Study Arms (3)

A

PLACEBO COMPARATOR
Drug: Placebo

B

EXPERIMENTAL
Drug: Aripiprazole

C

ACTIVE COMPARATOR
Drug: Haloperidol

Interventions

PlaceboDRUG

Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).

A
AripiprazoleDRUG

Tablets, oral, 15-30 mg, once daily, 12 weeks.

Also known as: Abilify
B
HaloperidolDRUG

Capsule, oral, 5-15 mg, once daily, 12 weeks.

C

Eligibility Criteria

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

You may qualify if:

  • Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

Local Institution

Anaheim, California, United States

Location

Local Institution

Cerritos, California, United States

Location

Local Institution

Garden Grove, California, United States

Location

Local Institution

National City, California, United States

Location

Local Institution

Pico Rivera, California, United States

Location

Local Institution

Riverside, California, United States

Location

Local Institution

San Diego, California, United States

Location

Local Institution

Washington D.C., District of Columbia, United States

Location

Local Institution

Maitland, Florida, United States

Location

Local Institution

Tampa, Florida, United States

Location

Local Institution

Shreveport, Louisiana, United States

Location

Local Institution

Albuquerque, New Mexico, United States

Location

Local Institution

Cleveland, Ohio, United States

Location

Local Institution

Oklahoma City, Oklahoma, United States

Location

Local Institution

DeSoto, Texas, United States

Location

Local Institution

Burgas, Bulgaria

Location

Local Institution

Novi Iskar, Bulgaria

Location

Local Institution

Pleven, Bulgaria

Location

Local Institution

Sofia, Bulgaria

Location

Local Institution

Varna, Bulgaria

Location

Local Institution

Osijek, Croatia

Location

Local Institution

Rijeka, Croatia

Location

Local Institution

Split, Croatia

Location

Local Institution

Zagreb, Croatia

Location

Local Institution

Zapopan, Jalisco, Mexico

Location

Local Institution

Mexico City, Mexico City, Mexico

Location

Local Institution

Col. Obispado, Nuevo León, Mexico

Location

Local Institution

Monterrey, Nuevo León, Mexico

Location

Local Institution

Fracc. Industrias, San Luis Potosí, Mexico

Location

Local Institution

Mérida, Yucatán, Mexico

Location

Local Institution

Nuevo León, Mexico

Location

Local Institution

Lima, Lima Province, Peru

Location

Local Institution

Lipetsk, Lipetsk Oblast, Russia

Location

Local Institution

Arkhangelsk, Russia

Location

Local Institution

Kazan', Russia

Location

Local Institution

Leningrad Region, Russia

Location

Local Institution

Moscow, Russia

Location

Local Institution

Nizhny Novgorod, Russia

Location

Local Institution

Saint Petersburg, Russia

Location

Local Institution

Samara, Russia

Location

Local Institution

Volgograd, Russia

Location

Local Institution

Florida, Gauteng, South Africa

Location

Local Institution

Pretoria, Gauteng, South Africa

Location

Local Institution

Berea, Kwa Zuluu Natal, South Africa

Location

Local Institution

Durban, KwaZulu-Natal, South Africa

Location

Related Publications (1)

  • Young AH, Oren DA, Lowy A, McQuade RD, Marcus RN, Carson WH, Spiller NH, Torbeyns AF, Sanchez R. Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study. Br J Psychiatry. 2009 Jan;194(1):40-8. doi: 10.1192/bjp.bp.108.049965.

    PMID: 19118324BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Interventions

AripiprazoleHaloperidol

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingButyrophenonesKetonesOrganic Chemicals

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 19, 2004

First Posted

November 22, 2004

Study Start

December 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

November 8, 2013

Record last verified: 2010-07

Locations

ME(7)PE(1)CR(4)US(15)RU(9)BU(5)ZA(4)