NCT00095719 - Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia | Biotech Hunter

Enrollment

125

Participants

Timeline

Start Date

December 31, 2003

Primary Completion Date

March 31, 2005

Study Completion Date

March 31, 2005

Conditions

DementiaAlzheimer's Disease

Interventions

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.

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.

Trial Locations (14)

Unknown

Local Institution, Santa Ana

Local Institution, Hamden

Local Institution, Hialeah

Local Institution, Miami

Local Institution, North Miami

Local Institution, Indianapolis

Local Institution, New York

Local Institution, Staten Island

Local Institution, Dayton

Local Institution, Oklahoma City

Local Institution, Tulsa

Local Institution, Hershey

Local Institution, Austin

Local Institution, Midvale