Efficacy and Safety Profile of Risperidone in Schizophrenia: Long-term Follow-up Study

Lee, Min Soo; Kim, Yong Ku; Kang, Byung Jo; Kim, Kwang Soo; Kim, Young Hoon; Kim, Hee Cheol; Na, Chul; Rho, Seung Ho; Paik, In Ho; Yeon, Byeong Kil; Oh, Byoung Hoon; Yoon, Doh Joon; Yoon, Jin Sang; Lee, Jong Bum; Lee, Chul; Jun, Tae Youn; Jung, In Kwa; Chung, In Won; Chee, Ik Seung; Chae, Jeong Ho; Han, Sang Ick; Suh, Kwang Yoon

Abstract

OBJECTIVES: The purpose of this study was to evaluate the long-term efficacy and safety of risperidone in the treatment of Korean schizophrenic patients. METHOD: This multicenter open label study included 116 schizophrenic patients drawn from 19 university hospitals. After a wash-out period of 1 week, the patients were treated with risperidone for 56 weeks and evaluated at 8 points:at baseline, and the 8th, 16th, 24th, 32nd, 40th, 48th, 56th weeks of treatment. The dose was started at 2mg of risperidone on day 1, and increased to 4mg on day 2, and 6mg on day 3,7 and adjusted to a maximum of 16mg/day according to the individual's clinical response. The psychiatric and neurological status of the patients was assessed by PANSS, CGI, and ESRS scales.
RESULTS
Eighty-seven(75%) of 116 patients completed the 56-week trial of risperidone. Clinical improvement(as defined by a 20% of reduction in total PANSS score at end point) was shown by 92.0% of the patients. The mean dose of risperidone was 5.0mg/day in the 56 week follow-up. PANSS total scores showed significant improvements between consecutive two points at baseline, 8th, 16th, 24th, 32nd, and 48th week of treatment. CGI scores showed significant reductions between consecutive two points at baseline, 8th, 16th, 24th, and 48th week of treatment. Three PANSS factors(positive, negative, general) showed a significant improvement from the 8th week of treatment, and, after then, remained improved in the rest of the study period. ESRS showed no significant change during the 56 week trial. Laboratory parameters showed no significant changes during the course of treatment.
CONCLUSIONS
This multicenter long-term open study suggests that risperidone is a antipsychotic drug with long term efficacy and safety in the treatment of schizophrenic patients.