Efficacy and Safety Profile of Risperidone in Schizophrenia: Open Multicenter Clinical Trial

Lee, Min Soo; Kim, Yong Ku; Kim, Young Hoon; Yeon, Byeong Kil; Oh, Byoung Hoon; Yoon, Doh Joon; Yoon, Jin Sang; Lee, Chul; Jeoung, Hee Yeon; Kang, Byung Jo; Kim, Kwang Soo; Kim, Dong Eon; Kim, Myung Jung; Kim, Sang Hun; Kim, Hee Cheol; Na, Chul; Rho, Seung Ho; Min, Kyung Joon; Park, Ki Chang; Park, Doo Byung; Paik, Ki Chung; Paik, In Ho; Son, Bong Ki; Sohn, Jin Wook; Yang, Byung Hwan; Yang, Chang Kook; Woo, Haing Won; Lee, Jung Ho; Lee, Jong Bum; Lee, Hong Shick; Lim, Ki Young; Jun, Tae Youn; Chung, Young Cho; Chung, Young Chul; Jung, In Kwa; Chung, In Won; Chee, Ik Seung; Chae, Jeong Ho; Han, Sang Ick; Han, Sun Ho; Han, Jin Hee; Suh, Kwang Yoon

Abstract

OBJECTIVE
The purpose of this study was to investigate the efficacy and safety of risperidone in the treatment of Korean schizophrenic patients. METHOD: This multicenter open study included 377 schizophrenic patients drawn from 39 university hospitals. After a wash-out period of 1 week, the schizophrenic patients were treated with risperidone for 8 weeks and evaluated at 5 points: at baseline, and 1,2,4 and 8 weeks of treatment. The dose was increased from 2mg/day(1mg twice daily) to 6mg/day(3mg twice daily) during the first week and adjusted to a maximum of 16mg/day over the next 7 weeks according to the patient's clinical response. Medication to control extrapyramidal symptoms was permitted. The psychiatric and neurological status of the patients was assessed by PANSS, CGI, and ESRS scales.
RESULTS
343(91%) of 377 patients completed the 8-week trial period. Clinical improvement, as defined by a 20% or more reduction in total PANSS score at end point, was shown by 81.3% of patients. The predictors of response to risperidone were associated older age, shorter duration of illness, fewer previous hospitalization. Risperidone had rapid onset of action: a significant decrease of the total PANSS and three PANSS factor(positive, negative, general), and CGI was already noticed at the end of first week. For the ESRS, parkinsonism rating scores were significantly increased until week 4 comparing with baseline. Dystonia rating scores were significantly increased until week 1, and dyskinesia rating scores were not significantly changed during the study. Laboratory parameters including vital sign, EKG, hematological, and biochemical values showed no significant changes during the trial.
CONCLUSIONS
This study suggests that risperidone is generally safe and effective against both the positive and negative symptoms in our group of patients.