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Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

NCT ID: NCT00095719

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2005-03-31

Brief Summary

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

Detailed Description

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Conditions

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Dementia Alzheimer's Disease

Keywords

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Acute agitation in patients diagnosed with Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

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.

B1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Santa Ana, California, United States

Site Status

Local Institution

Hamden, Connecticut, United States

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Local Institution

Hialeah, Florida, United States

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Miami, Florida, United States

Site Status

Local Institution

North Miami, Florida, United States

Site Status

Local Institution

Indianapolis, Indiana, United States

Site Status

Local Institution

New York, New York, United States

Site Status

Local Institution

Staten Island, New York, United States

Site Status

Local Institution

Dayton, Ohio, United States

Site Status

Local Institution

Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Local Institution

Hershey, Pennsylvania, United States

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Austin, Texas, United States

Site Status

Local Institution

Midvale, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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CN138-131

Identifier Type: -

Identifier Source: org_study_id