Risperidone versus haloperidol, in combination with lorazepam, in the treatment of acute agitation and psychosis: a pilot, randomized, double-blind, placebo-controlled trial.
OBJECTIVE
To compare oral risperidone and intramuscular (IM) haloperidol, both in combination with IM lorazepam, in the management of acute agitation and psychosis in the medical emergency department.


METHODS
In this prospective, randomized, placebo-controlled, double-blind study of 30 patients presenting to the emergency department with acute agitation and/or psychosis, three groups of 10 patients received oral and IM medications: 1) 2 mg oral risperidone and 2 mg IM lorazepam; 2) 5 mg oral haloperidol and 2 mg IM lorazepam; 3) oral placebo and 2 mg IM lorazepam. Each treatment group received both an injection and a tablet to reduce treatment group variability. Patients were evaluated using the Brief Psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS) before receiving medication and at 30 and 90 minutes after medication was administered. The intergroup mean percent reductions in rating scale scores were compared using ANOVA, chi-square, and Kruskal-Wallis tests.


RESULTS
There were no statistically significant differences among the groups at any point. The two groups receiving an antipsychotic plus lorazepam showed a trend towards increased symptom reduction compared with the group receiving lorazepam alone, although this trend was not statistically significant.


CONCLUSIONS
Lorazepam alone was as effective as lorazepam plus haloperidol or lorazepam plus risperidone in this small trial. While not statistically significant, a trend toward better outcomes with combined treatment warrants further study.
Veser
Frederick H
FH
Medical University of South Carolina, Charleston, 29455, USA. veserf@musc.edu
Veser
Belynda Dunn
BD
McMullan
Jason T
JT
Zealberg
Joseph
J
Currier
Glenn W
GW
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008140:Lorazepam / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011595:Psychomotor Agitation / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D018967:Risperidone / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D014151:Anti-Anxiety Agents; D014150:Antipsychotic Agents; D006220:Haloperidol; D018967:Risperidone; D008140:Lorazepam