A clinical evaluation of risperidone in the treatment of schizophrenia: a 10-week, open-label, multicenter trial

Abstract

The efficacy and safety of risperidone have previously been demonstrated in controlled clinical trials in hospitalized chronic schizophrenia patients who met strict research criteria. The present study was designed to evaluate the efficacy and safety of risperidone in a heterogeneous patient population. Patients were enrolled in the study if they had a diagnosis of schizophrenia (DSM-III-R) with or without acute exacerbation. Of the 945 patients from 158 psychiatric centers who entered this phase IV study, 558 completed the 10-week trial. During week 1, the dose of risperidone was titrated to 6 mg/day, maintained there for 1 week, and then adjusted over a 4-week period as clinically necessary; the dose was then fixed for the final 4-week period. The mean dose of risperidone at endpoint was 5.9 mg/day. Patients were evaluated at baseline and at weeks 2, 6, and 10, using Clinical Global Impression scale, Psychotic Symptoms Assessment scale, and Global Assessment of Functioning scale. Significant improvement in mean scores was found on each of these measures at endpoint. Comparable results were obtained at week 10 in treatment-resistant and non-treatment-resistant patients. Risperidone was generally well tolerated and the severity of extrapyramidal symptoms was significantly reduced at endpoint.

Risperidone in chronic schizophrenia: a detailed audit, open switch study and two-year follow-up of patients on depot medication

“…At 6 months, the outcome of the switch study was reasonably satisfactory for completers, who showed small, but significant, improvements over baseline in the domains of clinical status, treatment-related sideeffects and quality of life. These findings confirm similar improvements in symptomatology and EPS that have been shown in studies of short follow-up [7,13,10]. A standardised measure of quality of life also showed small significant improvements over the 6 months of the switch study.…”

Patient characteristics and prescription patterns of atypical antipsychotics among patients with schizophrenia

“…Third, clinical trials indicate that with average doses, patients with schizophrenia who were prescribed olanzapine gained more weight during a 10‐week period than those on risperidone (27, 28). Consistent with these findings based upon clinical trials, our study found that among patients who had a BMI ≥ 30, more patients were initiated on high doses of risperidone than on high doses of olanzapine.…”

New Antipsychotics, Compliance, Quality of Life, and Subjective Tolerability—Are Patients Better Off?

“…So far, few or no comparisons have been reported involving quetiapine, aripiprazole, and ziprasidone. A large noncomparative postmarketing study of schizophrenia patients treated with risperidone reported significant improvement in quality of life (58% of patients) by week 10, compared with only 25% at baseline (30). In another long-term study, 362 schizophrenia patients were switched from other antipsychotics to risperidone (31).…”