Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

Otsuka Pharmaceutical Development & Commercialization, Inc.125 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

125

Conditions

Dementia Alzheimer's Disease

Interventions

AripiprazoleDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 95 Years

Medical Language ↔ Plain English

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.

Locations (14)

Local Institution

Santa Ana, California, United States

Local Institution

Hamden, Connecticut, United States

Local Institution

Hialeah, Florida, United States

Outcomes

Primary Outcomes

tolerability

Secondary Outcomes

safety assessments

Data from ClinicalTrials.gov

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