Efficacy of Risperidone in Treatment-Resistant Patients with Chronic Schizophrenia

Lee, Hong Shick; Jeon, Ji Yong; Kim, Chan Hyung; Song, Dong Ho; Yook, Ki Whan; Kim, Byung Cheon; Sohn, Seok Han; Koo, Min Sung

Abstract

OBJECTS: This open study was designed to investigate the efficacy and safety of risperidone in the treatment-resistant patients with chronic schizophrenia. 24 patients were entered on the 8-week open trial. A total of 3 patients discontinued risperidone treatment before the end of the study.
METHODS
We investigated risperidone's efficacy and its side effects in 21 patients with treatment-resistant chronic schizophrenia, who had previously been treated with different kinds of classical antipsychotic drugs but with insufficient clinical effect or distressing extrapyramidal side effects, over a 8-week period. After 3- 7 days of placebo wash-out period, patients were assigned to receive risperidone. The overall clinical efficacy was assessed at the 1st, 2nd, 4th, and 8th week of the treatment using the PANSS and the CGI. Safety and tolerability were assessed by the ESRS, the UKU side effect rating scale, the vital signs, and the laboratory tests including CBC, urinalysis, liver function test, and ECG.
RESULTS
Clinically PANSS total score and CGI severity score on the end study point showed a significant improvement compared with baseline state. Significant improvements in both PANSS positive and negative subscale scores was as early as week 1 through week 8. Nine(43%) among of the 21 patients showed at least a 20% decrease in total PANSS scores. The tolerability of risperidone was geneally found to be good. Insomnia(52%), fatigue(52%), and sedation(52%) were the most common side effects.
CONCLUSION
These results suggest that risperidone may be a effective antipsychotic agent in the treatment of refractory schizophrenia. However, double-blind comparative trial between risperidone and clozapine should be performed to further clarify the efficacy of risperidone in treatment-resistant patients with chronic schizophrenia.