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Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00080314
Collaborator
Otsuka America Pharmaceutical (Industry)
400
Enrollment
28
Locations
2
Arms
33
Duration (Months)
14.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Oct 1, 2006
Actual Study Completion Date :
Oct 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A1

Drug: Aripiprazole
Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
Other Names:
  • Abilify

    		•
    Placebo Comparator: A2

    Drug: Placebo
    Tablets, Oral, 0 mg, Once daily, 8 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Change on a depression 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 to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • ages 18-65

    • Men and women, who have experienced a prior manic episode that required hospitalization, and now meet criteria for a major depressive episode.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Tuscaloosa Alabama United States
    2 Local Institution Little Rock Arkansas United States
    3 Local Institution San Diego California United States
    4 Local Institution Sherman Oaks California United States
    5 Local Institution Norwich Connecticut United States
    6 Local Institution West Haven Connecticut United States
    7 Local Institution Jacksonville Florida United States
    8 Local Institution Maitland Florida United States
    9 Local Institution Orlando Florida United States
    10 Local Insstitution Honolulu Hawaii United States
    11 Local Institution Chicago Illinois United States
    12 Local Institution Lake Charles Louisiana United States
    13 Local Institution Rockville Maryland United States
    14 Local Institution Durham North Carolina United States
    15 Local Institution Raleigh North Carolina United States
    16 Local Institution Beachwood Ohio United States
    17 Local Institution Dayton Ohio United States
    18 Local Institution Oklahoma City Oklahoma United States
    19 Local Institution Portland Oregon United States
    20 Local Institution Media Pennsylvania United States
    21 Local Institution Memphis Tennessee United States
    22 Local Institution Austin Texas United States
    23 Local Institution Dallas Texas United States
    24 Local Institution Houston Texas United States
    25 Local Institution Lake Jackson Texas United States
    26 Local Institution Wichita Falls Texas United States
    27 Local Institution Arlington Virginia United States
    28 Local Institution Bellevue Washington United States

    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

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00080314
    Other Study ID Numbers:
    • CN138-096
    First Posted:
    Mar 30, 2004
    Last Update Posted:
    Nov 11, 2013
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    Bipolar 1 Disorder, depressed
    Additional relevant MeSH terms:
    Disease
    Bipolar Disorder
    Aripiprazole

    Study Results

    No Results Posted as of Nov 11, 2013