Efficacy and safety of risperidone oral solution combination clonazepam oral versus haloperidol intramuscular injection for treatment of acute psychotic agitation in schizophrenia

Abstract

Objective To compare the efficacy and safety between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation in patients of acute schizophrenia or schizophrenic-affective disorder and to explore the possibility of decreasing efficacy of 6 week acute treatment from switching IM injection to oral.Method Altogether 205 patients exhibiting agitation were randomly assigned to receive either oral treatment with risperidone oral solution puls clonazepam ( n = 104) or intramuscular injection treatment with haloperidol ( n = 101 ).The primary efficacy outcome measure was the change in scores based on PANSS-EC in session Ⅰ ( the first five days), and the response rate based on the PANSS score in session Ⅱ ( the following 6 weeks).Safety was evaluated using the Simpson-Angus Scale (ASA), Barnes Akathisia Scale (BAS), adverse events and lab test.Result Mean acute-agitation score improvement was significant after 5 day treatment in both groups (P ＜0.01 ) and were similar in both groups ( P ＞ 0.05).While the cooperation was better and the advert events, especially extrapyramidal symptoms was lower in risperidone oral solution groups than that in haloperidol IM injection group(P ＜0.05).The mean PANSS-EC and PANSS scores remained stable after switching from IM injection to oral.The efficacy was not differenct in both groups after 6 week treatment (P ＞ 0.05).There was no significant difference at the rate of total advert events ( P ＞ 0.05 ) while there were yet significantly higher rates of extrapyramidal symptoms in switching drug group than that in oral group ( P ＜ 0.05 ).Conclusion Risperidone oral solution plus oral clonazepam has similar therapeutic effect to haloperidol IM injection in the treatment of acute agitation, but risperidone oral solution plus clonazepam has better compliance and tolerability.The illness is stable after switching from haloperidol IM injection to risperidone oral solution, in the following 6 week treatment. Key words: Schizophrenia; Risperidone; Haloperidol; Treatment outcome; Safety