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Study of Aripiprazole in Patients With Acute Bipolar Mania

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00097266
Collaborator
Otsuka America Pharmaceutical (Industry)
615
Enrollment
45
Locations
3
Arms
25
Duration (Months)
13.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder
Study Start Date :
Dec 1, 2004
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Jan 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: A

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

Drug: Aripiprazole
Tablets, oral, 15-30 mg, once daily, 12 weeks.
Other Names:
  • Abilify

    		•
    Active Comparator: C

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in a mania rating scale at endpoint []

    Secondary Outcome Measures

    1. Response rate and Clinical Global Impression scale at endpoint []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Anaheim California United States
    2 Local Institution Cerritos California United States
    3 Local Institution Garden Grove California United States
    4 Local Institution National City California United States
    5 Local Institution Pico Rivera California United States
    6 Local Institution Riverside California United States
    7 Local Institution San Diego California United States
    8 Local Institution Washington District of Columbia United States
    9 Local Institution Maitland Florida United States
    10 Local Institution Tampa Florida United States
    11 Local Institution Shreveport Louisiana United States
    12 Local Institution Albuquerque New Mexico United States
    13 Local Institution Cleveland Ohio United States
    14 Local Institution Oklahoma City Oklahoma United States
    15 Local Institution Desoto Texas United States
    16 Local Institution Burgas Bulgaria
    17 Local Institution Novi Iskar Bulgaria
    18 Local Institution Pleven Bulgaria
    19 Local Institution Sofia Bulgaria
    20 Local Institution Varna Bulgaria
    21 Local Institution Osijek Croatia
    22 Local Institution Rijeka Croatia
    23 Local Institution Split Croatia
    24 Local Institution Zagreb Croatia
    25 Local Institution Mexico Distrito Federal Mexico
    26 Local Institution Zapopan Jalisco Mexico
    27 Local Institution Col. Obispado Nuevo Leon Mexico
    28 Local Institution Monterrey Nuevo Leon Mexico
    29 Local Institution Fracc. Industrias San Luis Potosi Mexico
    30 Local Institution Merida Yucatan Mexico
    31 Local Institution Nuevo Leon Mexico
    32 Local Institution Lima Peru
    33 Local Institution Lipetsk Lipetsk Region Russian Federation
    34 Local Institution Arkhangelsk Russian Federation
    35 Local Institution Kazan Russian Federation
    36 Local Institution Leningrad Region Russian Federation
    37 Local Institution Moscow Russian Federation
    38 Local Institution Nizhniy Novgorod Russian Federation
    39 Local Institution Samara Russian Federation
    40 Local Institution St. Petersburg Russian Federation
    41 Local Institution Volgograd Russian Federation
    42 Local Institution Florida Gauteng South Africa
    43 Local Institution Pretoria Gauteng South Africa
    44 Local Institution Durban Kwa Zulu Natal South Africa
    45 Local Institution Berea Kwa Zuluu Natal South Africa

    Sponsors and Collaborators

    • Otsuka Pharmaceutical Development & Commercialization, Inc.
    • Otsuka America Pharmaceutical

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00097266
    Other Study ID Numbers:
    • CN138-162
    First Posted:
    Nov 22, 2004
    Last Update Posted:
    Nov 8, 2013
    Last Verified:
    Jul 1, 2010
    Keywords provided by , ,
    Bipolar Mania
    Additional relevant MeSH terms:
    Bipolar Disorder
    Haloperidol
    Aripiprazole
    Haloperidol decanoate

    Study Results

    No Results Posted as of Nov 8, 2013