PsychopharmacologySep 6, 2006

Intramuscular aripiprazole compared to haloperidol for calming sudden agitation in people with schizophrenia or schizoaffective disorder

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Updated Apr 6, 2026

Abstract

Mean improvement in the Positive and Negative Syndrome Scale Excited Component (PEC) score at 2 hours was -7.27 for IM aripiprazole compared to -4.78 for placebo.

IM aripiprazole was noninferior to IM haloperidol in PEC score improvement (-7.75).
Both IM aripiprazole and IM haloperidol showed significantly greater improvements than placebo across all secondary efficacy measures at 2 hours.
Patients receiving IM aripiprazole had a lower mean number of injections and a reduced percentage requiring benzodiazepines compared to those receiving placebo.
The incidence of extrapyramidal symptoms was similar for IM aripiprazole (1.7%) and placebo (2.3%), but lower than for IM haloperidol (12.6%).
IM aripiprazole was well tolerated in the study population.

Simplified

INTRODUCTION: This double-blind, placebo-controlled study investigated the efficacy and safety of intramuscular (IM) aripiprazole and IM haloperidol for the treatment of acute agitation in patients with schizophrenia or schizoaffective disorder.

MATERIALS AND METHODS: Four-hundred and forty-eight patients were randomized (2:2:1 ratio) to IM aripiprazole 9.75 mg, IM haloperidol 6.5 mg, or IM placebo. Patients could receive up to three injections over the first 24 h, with second and third injections administered > or =2 and > or =4 h, respectively, after the first if deemed clinically necessary. Primary efficacy measure was mean change in Positive and Negative Syndrome Scale Excited Component (PEC) score from baseline to 2 h.

RESULTS: Mean improvement in PEC at 2 h was significantly greater for IM aripiprazole (-7.27) vs placebo (-4.78; p<0.001); IM aripiprazole was noninferior to IM haloperidol (-7.75) on PEC. All secondary efficacy measures showed significantly greater improvements at 2 h for IM aripiprazole and IM haloperidol over placebo. Mean number of injections/patient and percentage of patients requiring benzodiazepines were significantly lower for IM aripiprazole vs placebo (p<0.01). IM aripiprazole was well tolerated. Extrapyramidal symptom-related adverse events were similar for aripiprazole (1.7%) and placebo (2.3%) and lower than with haloperidol (12.6%).

CONCLUSION: These results show that IM aripiprazole is an effective treatment, comparable to IM haloperidol, and well-tolerated for acute agitation in patients with schizophrenia.

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Intramuscular aripiprazole compared to haloperidol for calming sudden agitation in people with schizophrenia or schizoaffective disorder

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