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CompletedNCT00097266Updated Nov 8, 2013

Study of Aripiprazole in Patients With Acute Bipolar Mania

A Phase 3 interventional study of Placebo and Aripiprazole in Bipolar Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 45 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-08.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
615
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bipolar Disorder

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Keywords

  • Bipolar Mania
03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 615 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
615 participants

Study arms

  • Placebo comparator
    A

    Drug: Placebo

  • Experimental
    B

    Drug: Aripiprazole

  • Active comparator
    C

    Drug: Haloperidol

Interventions

  • DrugPlacebo

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

  • DrugAripiprazole

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

    Also known as: Abilify

  • DrugHaloperidol

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

06

What researchers measure

Primary outcomes

  1. Change in a mania rating scale at endpoint

Secondary outcomes

  1. Response rate and Clinical Global Impression scale at endpoint

07

Study locations

45 sites
  • Local Institution
    Anaheim, California, United States
  • Local Institution
    Cerritos, California, United States
  • Local Institution
    Garden Grove, California, United States
  • Local Institution
    National City, California, United States
  • Local Institution
    Pico Rivera, California, United States
  • Local Institution
    Riverside, California, United States
  • Local Institution
    San Diego, California, United States
  • Local Institution
    Washington, District of Columbia, United States
  • Local Institution
    Maitland, Florida, United States
  • Local Institution
    Tampa, Florida, United States
  • Local Institution
    Shreveport, Louisiana, United States
  • Local Institution
    Albuquerque, New Mexico, United States
  • Local Institution
    Cleveland, Ohio, United States
  • Local Institution
    Oklahoma City, Oklahoma, United States
  • Local Institution
    Desoto, Texas, United States
  • Local Institution
    Burgas, Bulgaria
  • Local Institution
    Novi Iskar, Bulgaria
  • Local Institution
    Pleven, Bulgaria
  • Local Institution
    Sofia, Bulgaria
  • Local Institution
    Varna, Bulgaria
  • Local Institution
    Osijek, Croatia
  • Local Institution
    Rijeka, Croatia
  • Local Institution
    Split, Croatia
  • Local Institution
    Zagreb, Croatia
  • Local Institution
    Mexico, Distrito Federal, Mexico
  • Local Institution
    Zapopan, Jalisco, Mexico
  • Local Institution
    Col. Obispado, Nuevo Leon, Mexico
  • Local Institution
    Monterrey, Nuevo Leon, Mexico
  • Local Institution
    Fracc. Industrias, San Luis Potosi, Mexico
  • Local Institution
    Merida, Yucatan, Mexico
  • Local Institution
    Nuevo Leon, Mexico
  • Local Institution
    Lima, Peru
  • Local Institution
    Lipetsk, Lipetsk Region, Russian Federation
  • Local Institution
    Arkhangelsk, Russian Federation
  • Local Institution
    Kazan, Russian Federation
  • Local Institution
    Leningrad Region, Russian Federation
  • Local Institution
    Moscow, Russian Federation
  • Local Institution
    Nizhniy Novgorod, Russian Federation
  • Local Institution
    Samara, Russian Federation
  • Local Institution
    St. Petersburg, Russian Federation
  • Local Institution
    Volgograd, Russian Federation
  • Local Institution
    Florida, Gauteng, South Africa
  • Local Institution
    Pretoria, Gauteng, South Africa
  • Local Institution
    Durban, Kwa Zulu Natal, South Africa
  • Local Institution
    Berea, Kwa Zuluu Natal, South Africa
08

References and documents

Publications

  • 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. PubMed 19118324 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00097266
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
First posted
Nov 22, 2004
Start date
Dec 2004
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Nov 8, 2013

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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