ABSTRACT
Objective: The study aimed to compare the efficacy and tolerability of oral risperidone and oral clonazepam with intramuscular haloperidol and oral clonazepam in Filipino patients with acute psychotic agitation. Methods: This study used a prospective randomized design targeting patients who were referred to the emergency department or hospital inpatients exhibiting both psychosis and agitation. Patients were randomized into oral risperidone group or intramuscular haloperidol group. Both groups received oral clonazepam as part of treatment. Patients were observed for 24 hours. The main efficacy parameter was the PANSS agitation cluster score. Other parameters were total PANSS, other PANSS subscale scores, time and incidence of additional clonazepam usage. The safety parameter measured as incidence of adverse events. Results: There were 99 subjects enrolled in the study: 49 in the oral risperidone arm and 50 in the intramuscular haloperidol arm. There were significant reductions in the mean PANSS agitation cluster scores for both groups: -7.6+4.7 for oral risperidone group (p<0.0001) and -6.7+5.0 for intramuscular haloperidol group (p<0.0001). There was no statistical difference observed in the mean change in PANSS agitation cluster scores among the two groups (p=0.3928). Similar trends were observed in the total PANSS and other subscale scores. The incidence of additional clonazepam use is numerically higher in the oral risperidone arm than the intramuscular haloperidol arm (33% vs. 20%), but the difference did not attain statistical significance (p=0.1370). At the end of the study, 17 (33 %) and 18 (36%) of patients in the risperidone and haloperidol groups experienced varying degrees of sedation. No serious adverse event was reported. Conclusion: Oral risperidone is comparable to intramuscular haloperidol in the treatment of acute psychotic agitation in terms of efficacy and safety.