Efficacy and Safety Profile of Risperidone in Schizophrenia: Open Multicenter Clinical Trial.
- Author:
Min Soo LEE
1
;
Yong Ku KIM
;
Young Hoon KIM
;
Byeong Kil YEON
;
Byoung Hoon OH
;
Doh Joon YOON
;
Jin Sang YOON
;
Chul LEE
;
Hee Yeon JEOUNG
;
Byung Jo KANG
;
Kwang Soo KIM
;
Dong Eon KIM
;
Myung Jung KIM
;
Sang Hun KIM
;
Hee Cheol KIM
;
Chul NA
;
Seung Ho RHO
;
Kyung Joon MIN
;
Ki Chang PARK
;
Doo Byung PARK
;
Ki Chung PAIK
;
In Ho PAIK
;
Bong Ki SON
;
Jin Wook SOHN
;
Byung Hwan YANG
;
Chang Kook YANG
;
Haing Won WOO
;
Jung Ho LEE
;
Jong Bum LEE
;
Hong Shick LEE
;
Ki Young LIM
;
Tae Youn JUN
;
Young Cho CHUNG
;
Young Chul CHUNG
;
In Kwa JUNG
;
In Won CHUNG
;
Ik Seung CHEE
;
Jeong Ho CHAE
;
Sang Ick HAN
;
Sun Ho HAN
;
Jin Hee HAN
;
Kwang Yoon SUH
Author Information
- Publication Type:Clinical Trial ; Multicenter Study ; Original Article
- Keywords: Schizophrenia; Risperidone; Efficacy; Safety
- MeSH: Dyskinesias; Dystonia; Electrocardiography; Hospitalization; Hospitals, University; Humans; Parkinsonian Disorders; Risperidone*; Schizophrenia*; Vital Signs; Weights and Measures
- From:Journal of Korean Neuropsychiatric Association 1998;37(1):60-74
- CountryRepublic of Korea
- Language:Korean
- 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.
