A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia
Abstract
Background This randomized, double-blind, placebo-controlled trial examined the efficacy and safety of risperidone in the treatment of aggression, agitation, and psychosis in elderly nursing-home patients with dementia. Method Elderly patients with a DSM-IV diagnosis of dementia of the Alzheimer's type, vascular dementia, or a combination of the 2 (i.e., mixed dementia) and significant aggressive behaviors were randomized to receive, for a period of 12 weeks, a flexible dose of either placebo or risperidone solution up to a maximum of 2 mg/day. Outcome measures were the Cohen-Mansfield Agitation Inventory (CMAI), the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) rating scale, and the Clinical Global Impression of Severity (CGI-S) and of Change (CGI-C) scales. Results A total of 345 patients were randomized to treatment with risperidone or placebo, and 337 patients received at least one dose of study drug. The trial was completed by 67% of patients in the placebo group and 73% of patients in the risperidone group. The mean +/- SE dose of risperidone was 0.95 +/- 0.03 mg/day. The primary endpoint of the study, the difference from baseline to endpoint in CMAI total aggression score, showed a significant reduction in aggressive behavior for risperidone versus placebo (p Conclusion Treatment with low-dose (mean = 0.95 mg/day) risperidone resulted in significant improvement in aggression, agitation, and psychosis associated with dementia.
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Several trials have investigated risperidone use in AD in the context of alleviating behavioral and psychological symptoms rather than as a potential treatment for AD.
“While several trials have investigated risperidone use in AD, this has been in the context of alleviating behavioral and psychological symptoms (e.g., agitation, hallucinations, and delusions) observed in some individuals with AD, rather than as a potential treatment for AD (Brodaty et al., 2003;Mintzer et al., 2006).”
From Drug repurposing for Alzheimer’s disease from 2012–2022—a 10-year literature review (2023) · cites this paper as Brodaty et al., 2003
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“, agitation, hallucinations, and delusions) observed in some individuals with AD, rather than as a potential treatment for AD (Brodaty et al., 2003; Mintzer et al., 2006).”
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- Authors
- Brodaty, H., Ames, D., Snowdon, J., Woodward, M., Kirwan, J., Clarnette, R., Lee, E., Lyons, B., & Grossman, F.
- Affiliations
- UNSW Sydney (AU)
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2003-02-15
- Volume
- 64
- Issue
- 2
- Pages
- 134-143
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W1985675058
- Cited by
- 464
- References
- 0
- Citations by year
- 2026: 3 · 2025: 10 · 2024: 9 · 2023: 7 · 2022: 11 · 2021: 4 · 2020: 10 · 2019: 9 · 2018: 12 · 2017: 10 · 2016: 9 · 2015: 9 · 2014: 17 · 2013: 17 · 2012: 10
- FWCI
- 35.54
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
- Keywords
- risperidone, dementia, aggression, agitation, psychosis, Alzheimer's disease, vascular dementia, mixed dementia, nursing home residents, older adults, antipsychotic efficacy, adverse events, sleepiness, urinary tract infection, extrapyramidal symptoms, Cohen-Mansfield Agitation Inventory, BEHAVE-AD, clinical global impression
- MeSH terms
- Aged, Aggression, Alzheimer Disease, Basal Ganglia Diseases, Double-Blind Method, Female, Homes for the Aged, Humans, Male, Placebos, Psychiatric Status Rating Scales, Psychomotor Agitation, Research Design, Antipsychotic Agents, Dementia, Vascular, Treatment Outcome, Risperidone
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