Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095719
• Other study ID #: CN138-131
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2004
• Last updated: November 7, 2013
• Start date: December 2003
• Est. completion date: March 2005

Study information

• Verified date: August 2008
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

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.
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tolerability
Secondary	safety assessments

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm