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A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia
De Deyn PP, Rabheru K, Rasmussen A, Bocksberger JP, Dautzenberg PL, Eriksson S, Lawlor BA.. Neurology, 1999-09-01
Topic: Risk, prevention and care in population studies
Objective To compare effects of risperidone with placebo (efficacy and tolerability) and haloperidol (tolerability) for treating demented patients with aggression and other behavioral symptoms. Methods A 13-week double-blind study involving 344 patients with dementia randomly assigned to receive placebo or flexible doses (0.5 to 4 mg/d) of risperidone or haloperidol. Behavioral symptoms were assessed by the Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD), the Cohen-Mansfield Agitation Inventory (CMAI), and the Clinical Global Impression (CGI) scale. Tolerability assessments included the Extrapyramidal Symptom Rating Scale, sedation levels, Functional Assessment Staging, Mini-Mental State Examination, and incidence of adverse events. Results The mean dose at endpoint was 1.1 mg/d of risperidone and 1.2 mg/d of haloperidol. Although not significant, a higher percentage of patients receiving risperidone than those receiving placebo showed clinical improvement (> or =30% reduction from baseline to endpoint in BEHAVE-AD total score) at endpoint and week 12. Reductions in the BEHAVE-AD total score were significantly greater with risperidone than with placebo at week 12. In a further analysis of aggression, the most dominant symptom in these patients, BEHAVE-AD and CMAI aggression cluster scores were significantly reduced compared with placebo at endpoint and week 12. CGI scores were also significantly reduced at endpoint and week 12. Severity of extrapyramidal symptoms with risperidone did not differ significantly from that of placebo and was less than that of haloperidol. A post hoc analysis showed significantly greater reductions in the BEHAVE-AD aggressiveness score with risperidone than haloperidol at week 12. Conclusion Low-dose risperidone (mean 1.1 mg/d) was well tolerated and associated with reductions in the severity and frequency of behavioral symptoms, particularly aggression, in elderly patients with dementia.
Key findings
- Results The mean dose at endpoint was 1.1 mg/d of risperidone and 1.2 mg/d of haloperidol.
- Although not significant, a higher percentage of patients receiving risperidone than those receiving placebo showed clinical improvement (> or =30% reduction from baseline to endpoint in BEHAVE-AD total score) at endpoint and week 12.
- Reductions in the BEHAVE-AD total score were significantly greater with risperidone than with placebo at week 12.
- In a further analysis of aggression, the most dominant symptom in these patients, BEHAVE-AD and CMAI aggression cluster scores were significantly reduced compared with placebo at endpoint and week 12.
- CGI scores were also significantly reduced at endpoint and week 12.
Why it matters
In this 13-week double-blind trial of 344 people with dementia, low-dose risperidone (mean 1.1 mg/d) produced significantly greater reductions than placebo on aggression scores (BEHAVE-AD and CMAI aggression clusters) and on clinician-rated global impression (CGI), but the share of patients reaching a ≥30% improvement in overall behavioural symptoms was not significantly higher than with placebo. Movement-related side effects with risperidone did not differ significantly from placebo and were lower than with haloperidol; an advantage over haloperidol on aggression came only from a post hoc analysis. The trial treated behavioural symptoms over 13 weeks and does not show any effect on Alzheimer's disease itself.
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Study details
- Participants344
- Evidence strengthLow
How this study scored 70/100
Published in a leading specialty 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 | 9 / 10 | Tier 2 — leading specialty journal (Neurology) |
| Journal's citation record | 4 / 4 | Neurology: journal h-index 525 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 1999 — older than 20 years, still counted |
| Sample size | 2 / 4 | 344 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 621 times (OpenAlex, 2026-10-10) |
| Citations per year | 4 / 5 | 21.4 citations a year over 29 year(s) since 1999 |
| Impact for its field and year | 5 / 6 | Cited 30.6× 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 17 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author BRIAN A. LAWLOR: h-index 83 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | University of Antwerp: institution h-index 834 (OpenAlex) |
| Multi-centre collaboration | 1 / 3 | OpenAlex lists 3 institution(s) in 3 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 10496251) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 70 / 100 | — |
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Read the original
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
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 names 7 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
APA 7th
De Deyn, P. P., Rabheru, K., Rasmussen, A., Bocksberger, J. P., Dautzenberg, P. L., Eriksson, S., et al. (1999). A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia. Neurology. https://doi.org/10.1212/wnl.53.5.946
Vancouver
De Deyn PP, Rabheru K, Rasmussen A, Bocksberger JP, Dautzenberg PL, Eriksson S, et al. A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia. Neurology. 1999. doi:10.1212/wnl.53.5.946. PMID: 10496251.
BibTeX
@article{dedeyn1999-10496251,
author = {De Deyn, P. P. and Rabheru, K. and Rasmussen, A. and Bocksberger, J. P. and Dautzenberg, P. L. and Eriksson, S. and Lawlor, B. A.},
title = {{A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia}},
journal = {Neurology},
year = {1999},
doi = {10.1212/wnl.53.5.946},
pmid = {10496251},
url = {https://doi.org/10.1212/wnl.53.5.946}
}
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