Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Safety & Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

125

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Ana, California, United States
        • Local Institution
    • Connecticut
      • Hamden, Connecticut, United States
        • Local Institution
    • Florida
      • Hialeah, Florida, United States
        • Local Institution
      • Miami, Florida, United States
        • Local Institution
      • North Miami, Florida, United States
        • Local Institution
    • Indiana
      • Indianapolis, Indiana, United States
        • Local Institution
    • New York
      • New York, New York, United States
        • Local Institution
      • Staten Island, New York, United States
        • Local Institution
    • Ohio
      • Dayton, Ohio, United States
        • Local Institution
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Local Institution
      • Tulsa, Oklahoma, United States
        • Local Institution
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Local Institution
    • Texas
      • Austin, Texas, United States
        • Local Institution
    • Utah
      • Midvale, Utah, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
tolerability

Secondary Outcome Measures

Outcome Measure
safety assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka America Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (ACTUAL)

March 1, 2005

Study Completion (ACTUAL)

March 1, 2005

Study Registration Dates

First Submitted

November 9, 2004

First Submitted That Met QC Criteria

November 8, 2004

First Posted (ESTIMATE)

November 9, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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