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Study of Aripiprazole in Patients With Acute Bipolar Mania

NCT ID: NCT00097266

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

615 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder

Keywords

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Bipolar Mania

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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A

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

B

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

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

C

Group Type ACTIVE_COMPARATOR

Haloperidol

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

Aripiprazole

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

Intervention Type DRUG

Haloperidol

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

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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Inclusion Criteria

* Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Anaheim, California, United States

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Cerritos, California, United States

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Garden Grove, California, United States

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National City, California, United States

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Pico Rivera, California, United States

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Riverside, California, United States

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San Diego, California, United States

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

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Maitland, Florida, United States

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Tampa, Florida, United States

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Shreveport, Louisiana, United States

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Albuquerque, New Mexico, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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DeSoto, Texas, United States

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Burgas, , Bulgaria

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Novi Iskar, , Bulgaria

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Pleven, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Osijek, , Croatia

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Rijeka, , Croatia

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Split, , Croatia

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Zagreb, , Croatia

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Zapopan, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Col. Obispado, Nuevo León, Mexico

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Monterrey, Nuevo León, Mexico

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Fracc. Industrias, San Luis Potosí, Mexico

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Mérida, Yucatán, Mexico

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Nuevo León, , Mexico

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Lima, Lima Province, Peru

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Lipetsk, Lipetsk Oblast, Russia

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Arkhangelsk, , Russia

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Kazan', , Russia

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Leningrad Region, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Volgograd, , Russia

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Florida, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Berea, Kwa Zuluu Natal, South Africa

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Durban, KwaZulu-Natal, South Africa

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Countries

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Chile United States Bulgaria Croatia Mexico Peru Russia South Africa

References

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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.

Reference Type BACKGROUND
PMID: 19118324 (View on PubMed)

Other Identifiers

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CN138-162

Identifier Type: -

Identifier Source: org_study_id