Open-label, observational study of the effects ofrisperidone on the behavioral and psychological symptoms of dementia and caregiver stress in the community setting

Abstract

Background: Behavioral disturbances and psychological symptoms of dementia—such as agitation, aggression, and psychosis—compromise patients' quality of life and daily functioning as well as contribute to caregiver burden and the decision to institutionalize the relative with the disease. Objective: The goal of this study was to examine the effects of risperidone on noncognitive symptoms and caregiver burden in the community setting. The tolerability of risperidone was also assessed. Methods: This was an observational, open-label, multicenter study. Dementia patients with behavioral and psychological symptoms received risperidone for 3 months. At 1 and 3 months, physicians rated symptoms on the Neuropsychiatric Inventory (NPI) and the Clinical Global Impression of Severity (CGI-S) scale. Caregivers rated their distress in relation to individual NPI items using the NPI Caregiver Distress (NPI-D) scale. Outcome variables were analyzed using Friedman and Wilcoxon tests. Results: A total of 263 patients (mean age, 77.5 years) received a mean (SD) risperidone dose of 1.4 (0.7) mg/d at 1 month and 1.5 (0.8) mg/d at 3 months. The total NPI score (mean [SEM]) decreased from 33.7 (1.91) at baseline to 11.9 (0.98) at month 3 ( P < 0.01), and the NPI-D score decreased from 22.5 (1.02) at baseline to 9.0 (0.64) at month 3 ( P < 0.01). Agitation/aggression and sleep disturbances were the most improved symptoms and caused the largest decrease in caregiver burden. Improvements were also noted on the CGI-S scale (from 4.0 at baseline to 3.4 at month 3; P < 0.01). Extrapyramidal symptoms decreased significantly ( P < 0.05) over the course of the study. Conclusions: In this study of community-based patients with dementia, risperidone significantly improved behavioral and psychological symptoms and, as a result, also reduced caregiver burden. Risperidone was well tolerated in this elderly population, particularly with regard to extrapyramidal symptoms.