Comparison of risperidone orodispersible tablet and intramuscular haloperidol in the treatment of acute psychotic agitation: a randomized open, prospective study.
OBJECTIVE
Psychotic agitation of psychiatric patients is a common manifestation that needs emergent management. Traditionally, parenteral or intramuscular injection of antipsychotics was conducted for treatment of psychotic agitation. Considering that the rapidly absorbed form of risperidone (risperidone orodispersible tablet) could be used for the agitated patient, comparison of oral risperidone and intramuscular haloperidol was performed in emergency treatment of psychotic agitation in this study.


METHODS
124 patients with psychotic agitation were recruited at the emergency room or inpatient ward. They were randomly assigned to either the group of oral risperidone or intramuscular haloperidol. Efficacy of both treatments was measured and compared using the 5-item acute agitation cluster from the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) and the Clinical Global Impression-Severity of Illness Scale (CGI-S). Tolerability and safety were also compared between the two groups.


RESULTS
The PANSS-EC and CGI-S scores were significantly decreased over time in both treatment groups without any significant group difference and time by group interaction effect (F = 459.7, p < 0.0001). There were no serious adverse events in both groups.


CONCLUSIONS
For the emergency treatment of psychotic agitation, risperidone orodispersible tablet was as effective and tolerable as intramuscular administration of haloperidol. Therefore, we might choose oral medication instead of intramuscular injection for treatment of patients with acute psychotic agitation.
Department of Psychiatry, The Catholic University of Korea, College of Medicine, Seoul, Korea.
Hyun Kook
HK
Lim
Jung Jin
JJ
Kim
Chi Un
CU
Pae
Chang Uk
CU
Lee
Chul
C
Lee
In Ho
IH
Paik
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage*; D006801:Humans; D007273:Injections, Intramuscular / Q000379:methods; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011595:Psychomotor Agitation / Q000150:complications / Q000188:drug therapy*; D011618:Psychotic Disorders / Q000150:complications / Q000188:drug therapy*; D018967:Risperidone / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D014150:Antipsychotic Agents; D006220:Haloperidol; D018967:Risperidone