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Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00095719
Collaborator
Otsuka America Pharmaceutical (Industry)
125
Enrollment
14
Locations
2
Arms
15
Duration (Months)
8.9
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to test the safety & tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia.

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 Safety & Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia
Study Start Date :
Dec 1, 2003
Actual Primary Completion Date :
Mar 1, 2005
Actual Study Completion Date :
Mar 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A1

Drug: Aripiprazole
IM Solution, IM, Cohort 1 - 2.5mg (.33cc) maximum dose 5.0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 5.0mg (.67cc) maximum dose 10 mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 10 mg (1.3cc) or 5.0 mg (.67cc) maximum dose 15mg; 1 injection, 24 hour observation for all cohorts.
Other Names:
  • Abilify

    		•
    Placebo Comparator: B1

    Drug: Placebo
    IM Solution, IM, Cohort 1 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 0mg; 1 injection, 24 hour observation for all cohorts.

    Outcome Measures

    Primary Outcome Measures

    1. tolerability []

    Secondary Outcome Measures

    1. safety assessments []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Acute agitation in Patients with a DSM-IV diagnosis of Alzheimer's, vascular or mixed Dementia.
    Exclusion Criteria:
    • Current DSM-IV Axis 1 diagnosis other than Alzheimer's, vascular or mixed Dementia.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Santa Ana California United States
    2 Local Institution Hamden Connecticut United States
    3 Local Institution Hialeah Florida United States
    4 Local Institution Miami Florida United States
    5 Local Institution North Miami Florida United States
    6 Local Institution Indianapolis Indiana United States
    7 Local Institution New York New York United States
    8 Local Institution Staten Island New York United States
    9 Local Institution Dayton Ohio United States
    10 Local Institution Oklahoma City Oklahoma United States
    11 Local Institution Tulsa Oklahoma United States
    12 Local Institution Hershey Pennsylvania United States
    13 Local Institution Austin Texas United States
    14 Local Institution Midvale Utah 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:
    NCT00095719
    Other Study ID Numbers:
    • CN138-131
    First Posted:
    Nov 9, 2004
    Last Update Posted:
    Nov 11, 2013
    Last Verified:
    Aug 1, 2008
    Keywords provided by , ,
    Acute agitation in patients diagnosed with Dementia
    Additional relevant MeSH terms:
    Alzheimer Disease
    Dementia
    Aripiprazole

    Study Results

    No Results Posted as of Nov 11, 2013