Efficacy of Long-term Treatment with Risperidone in Treatment-Resistant Patients with Schizophrenia / 대한정신약물학회지

OBJECTIVE: This open prospective study was performed to investigate the long-term efficacy and safety of risperidone in the treatment-resistant patient with chronic schizophrenia who had completed a 8-week short-term trial. METHOD: Fourteen patients with treatment-resistant chronic schizophrenia(DSM-IV), who had been previously treated with at least two different kinds of typical antipsychotic drugs but with insufficient clinical effects or who experienced distressing extrapyramidal side effects, were evaluated over a 48-week risperidone treatment period. Efficacy was assessed by the PANSS and the CGI, and its safety by the ESRS and the UKU side effect rating scale. Both were assessed at 8-week intervals. RESULT: Nine(four males and five females) of the fourteen patients completed the study. Overall, PANSS score for the entire period showed an improvement when compared with the baseline state. The pronounced improvement in CGI severity was seen between the 8th and 16th week, continued until endpoint. Of fourteen patients, eleven(78.6%) patients showed at least a 20% decrease in total PANSS scores on endpoint analysis. Transiently-observed extrapyramidal side effects following medication were akathisia(n=3), bradykinesia(n=3), and sialorrhea(n=2). Early UKU side effects included; increased dream activity, sedation, amenorrhea, and concentration difficulty. These were common but transient with the exception of amenorrhea. Three of the four patients with amenorrhea did not resume menses throughout the study. CONCLUSION: These results suggest that risperidone is a safe antipsychotic drug with long-term efficacy against both the positive and negative symptoms in the treatment of treatment-resistant schizophrenia.

Efficacy of Risperidone in Treatment-Resistant Patients with Chronic Schizophrenia / 대한정신약물학회지

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.