Agitation is a common symptom in schizophrenia and bipolar mania, causing marked distress and posing considerable risks for patients. Intramuscular formulations of psychotropic medication can provide a fast acting treatment of severe agitation in patients with acute episodes of schizophrenia or mania. As effective as these treatments are, particular antipsychotics can be associated with a heightened risk of dystonia and related Extrapyramidal Symptoms (EPS). Patients presenting to emergency care settings are also likely to have coexisting intoxications and medical conditions that may contribute to this risk.

The aim of this observational prospective study was to document the safety and effectiveness of all IM psychotropic drugs during the 24 hours following an initial injection in acutely agitated patients suffering from schizophrenia or bipolar disorder under naturalistic conditions.

Two-hundred-thirty-two (232) participating investigator sites (12 European countries) observed 1940 patients (mean age: 39 y, 42% female, 66% schizophrenia diagnosis). The primary endpoint was the occurrence of extrapyramidal symptoms (EPS), further endpoints were clinical severity measured by PANSS-EC and CGI-S. A total of 1311 (68%) patients received a monotherapy injection at baseline. Within 24 hours after the first injection, 190 (10%) of all 1940 patients experienced EPS. All intramuscular psychotropic drugs were shown to be effective in reducing measures of acute agitation.

This study provides favourable results on EPS related adverse events and effectiveness of intramuscular psychotropic medication for the management of acute agitation in patients within a naturalistic setting during the first 24 hours of treatment.