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A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia
Brodaty H, Ames D, Snowdon J, Woodward M, Kirwan J, Clarnette R, Lee E, Lyons B et al.. The Journal of clinical psychiatry, 2003-02-01
Topic: Risk, prevention and care in population studies
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.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Brodaty, H., Ames, D., Snowdon, J., Woodward, M., Kirwan, J., Clarnette, R., et al. (2003). A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia. The Journal of clinical psychiatry. https://doi.org/10.4088/jcp.v64n0205
Vancouver
Brodaty H, Ames D, Snowdon J, Woodward M, Kirwan J, Clarnette R, et al. A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia. The Journal of clinical psychiatry. 2003. doi:10.4088/jcp.v64n0205. PMID: 12633121.
BibTeX
@article{brodaty2003-12633121,
author = {Brodaty, H. and Ames, D. and Snowdon, J. and Woodward, M. and Kirwan, J. and Clarnette, R. and Lee, E. and Lyons, B. and others},
title = {{A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia}},
journal = {The Journal of clinical psychiatry},
year = {2003},
doi = {10.4088/jcp.v64n0205},
pmid = {12633121},
url = {https://doi.org/10.4088/jcp.v64n0205}
}
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
Key findings
- 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.
- 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 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 <.001).
Why it matters
In this 12-week randomized placebo-controlled trial of 345 nursing-home patients with dementia, low-dose risperidone (mean 0.95 mg/day) significantly reduced aggressive behavior compared with placebo. This addresses management of aggression and agitation symptoms, not curing or preventing Alzheimer's disease.
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Study details
- Participants345
- Evidence strengthHigh
How this study scored 68/100
Published in a peer-reviewed journal, and it is a randomised controlled trial. Scored zero for effect reported because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The Journal of clinical psychiatry) |
| Journal's citation record | 2 / 4 | The Journal of Clinical Psychiatry: journal h-index 248 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2003 — older than 20 years, still counted |
| Sample size | 2 / 4 | 345 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 6 / 7 | Cited 467 times (OpenAlex, 2026-10-10) |
| Citations per year | 3 / 5 | 18.7 citations a year over 25 year(s) since 2003 |
| Impact for its field and year | 5 / 6 | Cited 34.6× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 3 / 6 | Cited by 16 other studies in this library |
| Still being cited | 2 / 4 | Cited 22 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 1 / 4 | Last-listed author Fred Grossman: h-index 12 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | UNSW Sydney: institution h-index 1,101 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 12633121) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 68 / 100 | — |
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