Background: Risperidone significantly improves behavioral and psychological symptoms of dementia (BPSD), including aggression, agitation and psychosis, as shown by randomized, placebo-controlled trials.

MethodsAn 8-week, multicenter, naturalistic, open-label study was carried out to examine whether the benefits of risperidone apply to clinical practice. A total of 4499 patients were treated with risperidone at flexible doses chosen by physicians, and were included in the safety evaluation. Of these, 3909 patients met the intended study criteria (at least 65 years of age, dementia, and the presence of BPSD) and were included in the efficacy analyses.

Results:At the end of the study (after 8 weeks of treatment), risperidone (average final dose 1.6 mg/day) significantly improved all symptoms studied (agitation, aggressiveness, disturbance of the sleep–wake rhythm, social withdrawal, suspiciousness and delusions) as rated by physicians on a five-point scale of severity. On a four-point scale of global efficacy, more than 90% of patients were rated improved by both physicians and caregivers after 8 weeks of treatment. A significant improvement in sleep-wake cycle disturbances was also noted. A total of 422 adverse events were documented in 346 of the 4499 patients (7.7%); these included insufficient efficacy (2.6%), extrapyramidal symptoms (0.89%), deterioration of psychiatric symptoms (0.73%), sedation (0.56%), gastrointestinal disturbances (0.49%), cardiovascular disorders (0.38%), and cerebrovascular adverse events (0.36%).

Conclusions: Risperidone is an effective and well-tolerated treatment for BPSD in routine clinical practice.