A randomized, double-blind, placebo-controlled tolerability study of intramuscular aripiprazole in acutely agitated patients with Alzheimer's, vascular, or mixed dementia.

OBJECTIVES: To evaluate the tolerability of intramuscular (IM) aripiprazole in patients with agitation associated with dementia. DESIGN: A 24-hour, double-blind, placebo-controlled, randomized study. SETTING: Sixteen healthcare facilities in the United States. PARTICIPANTS: A total of 129 patients with acute agitation associated with Alzheimer's, vascular or mixed dementia in healthcare facilities. INTERVENTION: Patients were randomized to IM aripiprazole (5 mg, 10 mg, or 15 mg) or IM placebo administered in divided doses 2 hours apart. MEASUREMENTS: Safety assessments included adverse event (AE) reporting, vital signs, and electrocardiograms. Preliminary efficacy analyses used the Positive and Negative Syndrome Scale-Excited Component (PEC) scores and Agitation-Calmness Evaluation Scale (ACES). RESULTS: There was greater incidence of AEs with IM aripiprazole (50% to 60%) than IM placebo (32.0%), but over 90% were mild or moderate in severity. The incidence of oversedation was low. PEC scores showed greater improvements in agitation with IM aripiprazole 10 mg and 15 mg compared with IM placebo. CONCLUSION: A total of 10 mg or 15 mg of IM aripiprazole administered in divided doses was safe and well tolerated for treatment of agitation associated with Alzheimer's, vascular, or mixed dementia in long-term care. Preliminary analysis showed greater efficacy compared with IM placebo.