Abstract
Objective: Intramuscular (IM) Benzodiazepines and/or Haloperidol alone or with benzodiazepines are frequently used to treat agitation. Based on emerging literature regarding Quetiapine used for the control of anxiety we examined Quetiapine as a possible alternative in selected cases. Methods: This study was a single-blind randomized study comparing Quetiapine PO (300 mg) with a combination of Haloperidol (5 mg), Benztropine mesylate (2 mg) and lorazepam (2 mg) administered IM to treat agitated patients seeking care in a busy psychiatric emergency setting. Male or female patients (18 - 60), deemed by the attending (admitting) psychiatrist to be indicative of agitated and/or aggressive behavior and had a Positive and Negative Syndrome Score-Excited Component (PANSS-EC), as evaluated by the Research Psychiatrist, and total score equal to or greater than 15. Patients deemed competent were randomized into one of the following treatment groups: Quetiapine 300 or Haloperidol 5 mg, benztropine mesylate, or lorazepam given by the IM route. Two scales, PANSS-EC and CGI-C were used to assess patients in the trial. The primary outcome measure PANSS-EC at 2 hours after administration of the medication. Results: Sixty-eight patients were included in the study. There were no significant treatment group differences in baseline condition. There was no significant difference between the two conditions. There was, however, a significant within-group decrease from baseline condition. Conclusion: Finding no significant differences suggests that in general the two treatments were equivalent. To sum up, Quetiapine 300 mg as a single dose appeared safe and effective in agitated patients treated in an ER. The results were similar to a comparison group receiving an intra-muscular combination of Haloperidol, Lorazepam and Benztropine. This study has significant limitations. The study was single blind and the use of a placebo would have strengthened the design but would be considered unethical. The sample size was relatively small and the group of patients who come to the ER may not be representative of the population of patients who visit across the country. And finally it was a select subgroup who made up the study population and who were probably less severely ill than other subjects who came to our ER.
Highlights
The treatment of agitation in the psychiatric emergency room (ER) has changed little in the last decades
The secondary outcome measure was a binary indicator of improvement defined as a Clinical global Impression of Change (CGI-C) score of “much improved” or “very much improved” at 2 hours and/or a 20% reduction in PANSS-EC 2 hours following administration of the medication
The finding of no significant differences does not prove that there are no differences, the present study suggests that in general the two treatments were effective in the treatment of acute symptoms of agitation in the emergency setting The haloperidol mixture did have an nearly statistically significant advantage on one of the secondary outcome measures: a binary indicator of improvement defined as a CGI-C score of “much improved” or “very much improved” at 2 hours and/or a 20% or greater reduction in PANNS-EC 2 hours following administration of the medication
Summary
The treatment of agitation in the psychiatric emergency room (ER) has changed little in the last decades. Studies of liquid preparations represent a possible alternative for some patients, given their faster absorption compared with tablets or capsules similar to rapid dissolve tablets. The ideal would be a range of options, for example, benzodiazepine or antipsychotic and in turn tablet/capsule, liquid, rapid dissolve tablets or IM preparations. A recent study showed that inhaled loxapine may offer a further option to control agitation, as peak concentrations are obtained comparable to parenteral administration [1]. One of us (RM) began to use quetiapine in increasing dosages up to 300 mg in selected patients seeking treatment at the USC ER, based on emerging literature regarding quetiapine use for the control of anxiety [2]-[4]
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