Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

Phase 3

Completed

• Conditions: Dementia; Alzheimer's Disease
• Interventions: Drug: Aripiprazole; Drug: Placebo

• Registration Number: NCT00095719
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted QC: 2004-11-08
• Study First Submitted: 2004-11-09
• Study First Posted: 2004-11-09
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2008-08
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1	Aripiprazole	-
B1	Placebo	-

Primary Outcome Measures

Name	Time	Method
tolerability

Secondary Outcome Measures

Name	Time	Method
safety assessments

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Midvale, Utah, United States