A prospective, observational study of the safety and effectiveness of intramuscular psychotropic treatment in acutely agitated patients with schizophrenia and bipolar mania

Abstract

This naturalistic, observational pan-European study assessed the safety and early effectiveness of intramuscular (IM) psychotropic treatments in patients with acute agitation suffering from schizophrenia or bipolar mania. One thousand nine hundred and forty of 1945 patients completed the 24-hour observation period after initial IM treatment. Patients from 12 European countries were included (mean age 39 years; 58% male, 66% schizophrenia). IM treatment was at the physician's discretion. The primary objective was to describe the acute tolerability of IM psychotropic therapies in clinical practice, with particular emphasis on EPS. At baseline, 68% of the patients received IM monotherapy, with IM olanzapine most commonly prescribed (36%). During the first 24 hours, 190 (9.8%) patients experienced EPS. The occurrence of EPS was statistically significantly lower in patients treated with IM olanzapine compared to those treated with other IM psychotropic medications (mainly typical antipsychotics and benzodiazepines): acute dystonia: 1.1%, 95% CI 0.5-2.3 and 2.9%, CI 2.0-4.0; akathisia: 2.3%, CI 1.3-3.7 and 5.5%, CI 4.3-6.9; Parkinsonism: 2.9%, CI 1.8-4.4 and 7.8%, CI 6.4-9.4, respectively. Anticholinergic treatment was given to 12% IM olanzapine versus 31% non-olanzapine treated patients. Acute agitation after 24 hours was reduced by 1.68 (95% CI 1.46-1.91) points on the Clinical Global Impression of Severity (CGI-S) in IM olanzapine patients and 1.51 (95% CI 1.30-1.73) points in non-olanzapine patients. Additional psychotropic medication was required for 90% of the patients during the first 24 hours of treatment. Results provide naturalistic evidence for low EPS rates and improvement of agitation with IM psychotropic medications during acute states of patients suffering from acute mania or schizophrenia.

Treatment of agitation in the acute psychiatric setting. An observational study of the effectiveness of intramuscular psychotropic medication

“…In some published observational studies the levels of agitation are similar to those presented here (23)(24)(25)(26)(27). These studies have demonstrated various degrees of effect of intramuscular psychotropics.…”

“…The main focus of this study was to describe acute tolerability of intramuscular psychotropics, with particular emphasis on extrapyramidal symptoms. Data on comorbid substance abuse are not reported (24). One study focused on the effect of intramuscular ziprasidone on severe agitation in a naturalistic setting using a different score (Behavioural Activity Rating Scale) and demonstrated effectiveness also in cases of substance abuse (25).…”

A naturalistic comparison of the efficacy and safety of intramuscular olanzapine and intramuscular haloperidol in agitated elderly patients with schizophrenia

“…The findings also are consistent with those of previously conducted research [Perrin et al 2012;Satterthwaite et al 2008]. …”

A naturalistic comparison of the efficacy and safety of intramuscular olanzapine and intramuscular levomepromazine in agitated elderly patients with schizophrenia

“…These findings are consistent with those of previous studies 30–32. However, the mean score of the AIMS at baseline for the two groups differed significantly, which is a limitation of these findings.…”