Intramuscular Aripiprazole for the Treatment of Acute Agitation Associated with Schizophrenia: Sub-analysis of a Double-blind, Controlled, Dose-ranging Study

Objective: To evaluate efficacy and safety of intramuscular (IM) aripiprazole and IM haloperidol in patients with acute agitation associated with schizophrenia. Methods: Patients (n=232) were randomized to IM aripiprazole 1mg (0.5ml of a 2mg/ml solution), 5.25mg (0.7ml of a 7.5mg/ml solution to approximate 5mg), 9.75mg (1.3ml of a 7.5mg/ml solution to approximate 10mg), or 15mg (2.0ml of a 7.5mg/ml solution), IM haloperidol 7.5mg (1.5ml of a 5mg/ml solution) or IM placebo. Over 24 hours, patients received up to three injections, administered ≥2 hours apart. Primary endpoint was mean change from baseline in Positive and Negative Syndrome Scale Excited Component (PEC) score at 2 hours. Secondary endpoints included CGI-I, CGI-S and ACES scores. Results: Mean PEC improvements at 2 hours were significantly greater with IM aripiprazole 5.25, 9.75 and 15mg, and IM haloperidol vs. IM placebo. Compared with IM placebo, mean improvements were significantly greater in CGI-S with IM aripiprazole 9.75 and 15mg, and in ACES with IM aripiprazole 9.75mg and IM haloperidol. Mean CGI-I was significantly better with IM aripiprazole 5.25, 9.75 and 15mg, and IM haloperidol vs. IM placebo. Overall, IM aripiprazole was well tolerated, with fewer extrapyramidal side effects vs. IM haloperidol. Conclusion: IM aripiprazole 9.75mg is effective and well-tolerated for acute agitation

This study was supported by Bristol-Myers Squibb