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Divalproex sodium in nursing home residents with possible or probable Alzheimer Disease complicated by agitation: a randomized, controlled trial
Tariot PN, Raman R, Jakimovich L, Schneider L, Porsteinsson A, Thomas R, Mintzer J, Brenner R et al.. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry, 2005-11-01
Topic: Amyloid, tau and blood-test diagnosis
Objective Three placebo-controlled clinical trials have suggested the benefit of valproate for treatment of agitation associated with dementia; one was used as the basis for this multicenter trial, conducted by the Alzheimer's Disease (AD) Cooperative Study. It addresses the efficacy, safety, and tolerability of divalproex sodium for the treatment of agitation associated with dementia. Methods This was a randomized, double-blind, placebo-controlled clinical trial in 153 nursing home residents with probable or possible AD complicated by agitation; 110 (72%) completed the trial. Participants were randomized to treatment with divalproex sodium at a target dose of 750 mg/day (N = 75) or placebo (N = 78) for 6 weeks. The primary outcome measure was change from baseline on the Brief Psychiatric Rating Scale (BPRS) Agitation factor. Secondary outcomes included total BPRS, Clinical Global Impression of Change, Cohen-Mansfield Agitation Inventory score, and measures of safety and tolerability. Results Compliance averaged 88%. Participants receiving divalproex achieved a mean dose of 800 mg/day. Change in mean BPRS Agitation factor scores did not differ between patients treated with divalproex and placebo, nor did secondary behavioral measures. Measures of safety and tolerability did not reveal clinically important drug/placebo differences. Conclusions This multicenter trial showed no benefit of divalproex sodium for treatment for agitation in dementia at a mean dose of 800 mg/day over 6 weeks. The results do not support findings from previous trials indicating possible benefit.
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APA 7th
Tariot, P. N., Raman, R., Jakimovich, L., Schneider, L., Porsteinsson, A., Thomas, R., et al. (2005). Divalproex sodium in nursing home residents with possible or probable Alzheimer Disease complicated by agitation: a randomized, controlled trial. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry. https://doi.org/10.1176/appi.ajgp.13.11.942
Vancouver
Tariot PN, Raman R, Jakimovich L, Schneider L, Porsteinsson A, Thomas R, et al. Divalproex sodium in nursing home residents with possible or probable Alzheimer Disease complicated by agitation: a randomized, controlled trial. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry. 2005. doi:10.1176/appi.ajgp.13.11.942. PMID: 16286437.
BibTeX
@article{tariot2005-16286437,
author = {Tariot, P. N. and Raman, R. and Jakimovich, L. and Schneider, L. and Porsteinsson, A. and Thomas, R. and Mintzer, J. and Brenner, R. and others},
title = {{Divalproex sodium in nursing home residents with possible or probable Alzheimer Disease complicated by agitation: a randomized, controlled trial}},
journal = {The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry},
year = {2005},
doi = {10.1176/appi.ajgp.13.11.942},
pmid = {16286437},
url = {https://doi.org/10.1176/appi.ajgp.13.11.942}
}
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Key findings
- Objective Three placebo-controlled clinical trials have suggested the benefit of valproate for treatment of agitation associated with dementia; one was used as the basis for this multicenter trial, conducted by the Alzheimer's Disease (AD) Cooperative Study.
- It addresses the efficacy, safety, and tolerability of divalproex sodium for the treatment of agitation associated with dementia.
- The results do not support findings from previous trials indicating possible benefit.
Why it matters
In this 6-week randomized, double-blind, placebo-controlled trial of 153 nursing home residents with Alzheimer disease and agitation, divalproex sodium did not differ from placebo on the primary agitation measure or on secondary behavioral measures. The results do not support findings from previous trials indicating possible benefit.
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Study details
- Participants75
- Evidence strengthHigh
How this study scored 64/100
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 American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry) |
| Journal's citation record | 2 / 4 | American Journal of Geriatric Psychiatry: journal h-index 178 (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 | 2005 — older than 20 years, still counted |
| Sample size | 1 / 4 | 75 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 | 5 / 7 | Cited 114 times (OpenAlex, 2026-10-10) |
| Citations per year | 2 / 5 | 5.0 citations a year over 23 year(s) since 2005 |
| Impact for its field and year | 3 / 6 | Cited 5.2× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 2 / 6 | Cited by 4 other studies in this library |
| Still being cited | 1 / 4 | Cited 8 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 4 / 4 | Last-listed author Pierre N. Tariot: h-index 102 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | University of Rochester Medicine: institution h-index 953 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 16286437) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 64 / 100 | — |
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