Efficacy and safety of intranasal haloperidol in an acute Psychiatry Unit: a pilot study on schizophrenic patients with mild-modedate agitation

Abstract

Aim. To study the efficacy and safety of intranasal administration of 5 mg haloperidol on mild-moderate agitated patients with schizophrenia or schizoaffective disorder in an acute psychiatry unit setting.

Method. Design: Pilot study of clinical trial, phase IV, open-label, observer-blind, single-center, randomized a haloperidol-controlled trial comparing intranasal with intramuscular administration. Subjects: 16 patients; 7 intranasal administration, and 9 intramuscular administration. Efficacy measurement: Positive and Negative Syndrome Scale-Excited Component (PANSS-EC); Clinical Global Impressions-Improvement Scale (CGI). Safety measurement: Changes in the ECG registered 5 minutes pre-treatment and 5 minutes post-treatment.

Results. Intranasal administration showed more quick action compared with intramuscular on the PANSS-EC (p=0.042) and CGI (p=0.041) 10 minutes after administration, with similar efficacy up to 20, 30, and 60 minutes. There were no significant differences between QTc baseline and post-treatment.

Conclusion. Intranasal haloperidol was a rapid, effective, and well-tolerated alternative for reducing acute mildmoderate agitation.