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Intramuscular aripiprazole for the treatment of acute agitation associated with schizophrenia: Sub-analysis of a double-blind, controlled, dose-ranging study

Published online by Cambridge University Press:  16 April 2020

D.A. Oren ,
G. Manos ,
O. Markovic  and
R.D. McQuade
D.A. Oren
Affiliation:
Bristol-Myers Squibb Company, Wallingford, CT, USA
G. Manos
Affiliation:
Bristol-Myers Squibb Company, Wallingford, CT, USA
O. Markovic
Affiliation:
Bristol-Myers Squibb Company, Prague, Czech Republic
R.D. McQuade
Affiliation:
Otsuka Pharmaceutical Co Ltd., Princeton, NJ, USA

Abstract

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Background and aims:

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 1-mg (0.5 ml of a 2-mg/ml solution), 5.25-mg (0.7 ml of a 7.5-mg/ml solution to approximate 5-mg), 9.75-mg (1.3 ml of a 7.5-mg/ml solution to approximate 10-mg), or 15-mg (2.0 ml of a 7.5-mg/ml solution), IM haloperidol 7.5-mg (1.5 ml of a 5-mg/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 15-mg, and IM haloperidol versus IM placebo (Table). Compared with IM placebo, mean improvements were significantly greater in CGI-S with IM aripiprazole 9.75- and 15-mg, and in ACES with IM aripiprazole 9.75-mg and IM haloperidol (Table). Mean CGI-I was significantly better with IM aripiprazole 5.25-, 9.75- and 15-mg, and IM haloperidol versus IM placebo (Table). Overall, IM aripiprazole was well tolerated, with fewer extrapyramidal side effects versus IM haloperidol.

Conclusion:

IM aripiprazole 9.75-mg is effective and well-tolerated for acute agitation associated with schizophrenia.

Type
Poster Session 1: Schizophrenia and Other Psychosis
Information
European Psychiatry , Volume 22 , Issue S1: 15th AEP Congress - Abstract book - 15th AEP Congress , March 2007 , pp. S124 - 124
Copyright
Copyright © European Psychiatric Association 2007
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