Risperidone for the Treatment of Schizophrenia (1998)

SUMMARY Results of an open-label trial of risperidone In the treatment of schizophrenia involving 30 subjects are reported. During the 8-week long trial, the overall improvement rate was 87%. Risperidone treatment improved both positive and negative symptoms while its side-effects were generally mild and tolerable. Our findings also suggest that risperidone can be used as a first line treatment for schizophrenia. Keywords: risperidone, schizophrenia, effectiveness, Chinese INTRODUCTION Risperidone, a new, atypical antipsychotic drug, was developed by Janssen Pharmaceutica (Belgium) in 1984. It has a strong antagonistic effect on 5-HT2 receptors and moderate antagonistic action on D2 receptors in the central nervous system. Risperidone has been used in clinical practice since 1993 and proved to be efficacious far both negative and positive symptoms of schizophrenia. It has only mild extrapyramidal side effects (EPS) hence a eider safety margin than most traditional antipsychotic drugs. Here we report the results of an open label clinical trial of risperidone in the treatment of schizophrenia. METHODS All 30 patients entering the study met both ICD-10 and DSM-IV diagnostic criteria for schizophrenia. Patients with medical and neurological conditions and/or a history of alcohol or drug abuse were excluded from the study. Ad subjects were male with a mean age of 29.1 [+ or -] 8.9 years (range : 16-59 years); 83% of the subjects were between 19 and 35 years of age. The duration of illness ranged from 2 months to 25 years (mean : 5.97 [+ or -] 6.03 years). According to ICD-10 diagnostic criteria, subtype diagnoses of schizophrenia were as follows : 11 paranoid type, 8 undifferentiated type, 4 hebephrenic type, 2 residual type, 1 simple type and 4 other, ie. not identifiable, subtype. Only 12 patients had received antipsychotic medication prior to the study. Of these 12 subjects, 8 responded to previous neuroleptic treatment. Xian-Janssen Pharmceutica provided risperidone tablets of 1 mg strength and identical-hooking placebo tablets. The initial dose of risperidone was set at 1mg/day. Thereafter, the dose was increased according to the patients' clinical condition. The maximum dose was 10 mg/day. Among the 12 patients who had received previous antipsychotic treatment, 10 underwent a single-bind, one-week wash-out period using 1 placebo tablet twice a day. The whole trial lasted eight weeks. During the trial the administration of anti-parkinson drugs or benodiazepines was permitted. Assessment was made at baser and at the 1st, 2nd, 4th, 6th and 8th weeks of treatment by using the Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI) and the Treatment Emergent Side Effects Scale (TESS). We also used our traditional clinical evaluation to obtain an estimation of global improvement at the end of the trial. Laboratory investigations included full blood picture, liver and renal function tests, serum electrolytes and urinalysis. ECG and EEG were evaluated at baseline and at the 4th and 8th weeks of treatment. For statistical analysis, paired t-test, group Most and chi-square-test were used. Statistical significance was predetermined at the p RESULTS EFFECTIVENESS OF RISPERIDONE TREATMENT 29 patients completed the study; 1 subject dropped unit at the 5th week because of cerebral thrombus unrelated do risperidone therapy. According to our traditional clinical evaluation, 13 subjects (43.3%) was Judged as completely free of symptoms, 9 (30%) remarkably improved, 4 improved and 4 remained unchanged. Overall improvement rate was 87 %. BPRS total score shoved a significant decrease throughout the trial period (Table 1) Changes in BPRS factor scores during risperidone treatment are shown in Table 2. The majority of boors decreased significantly except for factor 1 in the first week. …