TY - JOUR
T1 - Placebo-controlled study of divalproex sodium for agitation in dementia
AU - Porsteinsson, Anton P.
AU - Tariot, Pierre N.
AU - Erb, Rosemary
AU - Cox, Christopher
AU - Smith, Elizabeth
AU - Jakimovich, Laura
AU - Noviasky, John
AU - Kowalski, Nancy
AU - Holt, Connie J.
AU - Irvine, Carrie
N1 - Funding Information:
This work was supported by the Alzheimer's Association ( RG1-96-023 ), the National Institute on Aging (via a pilot grant from the Rochester Alzheimer's Disease Core Center , AG-08665 ), and by an unrestricted investigator-initiated grant from Abbott Laboratories. Divalproex sodium was donated by Abbott Laboratories, Abbott Park, IL. Drug and placebo formulation were provided by the Monroe Community Hospital Department of Pharmacy.
PY - 2001
Y1 - 2001
N2 - The authors assessed the efficacy, tolerability, and safety of divalproex sodium for the treatment of agitation associated with dementia in a 6-week, randomized study of 56 nursing home patients with agitation and dementia treated with either placebo or individualized doses of divalproex sodium. Participants were blinded to treatment except for a physician-monitor and a pharmacist. When several covariates were taken into account, the drug/placebo difference in Brief Psychiatric Rating Scale Agitation scores became statistically significant (P = 0.05). Sixty-eight percent of patients on divalproex were rated as showing reduced agitation on the Clinical Global Impression scale, vs. 52% on placebo (P = 0.06 in the adjusted analysis). Side effects occurred in 68% of the divalproex group vs. 33% of the placebo group (P = 0.03) and were generally rated as mild. This placebo-controlled study, despite some limitations, suggests possible short-term efficacy, tolerability, and safety of divalproex for agitation in dementia and supports further placebo-controlled studies.
AB - The authors assessed the efficacy, tolerability, and safety of divalproex sodium for the treatment of agitation associated with dementia in a 6-week, randomized study of 56 nursing home patients with agitation and dementia treated with either placebo or individualized doses of divalproex sodium. Participants were blinded to treatment except for a physician-monitor and a pharmacist. When several covariates were taken into account, the drug/placebo difference in Brief Psychiatric Rating Scale Agitation scores became statistically significant (P = 0.05). Sixty-eight percent of patients on divalproex were rated as showing reduced agitation on the Clinical Global Impression scale, vs. 52% on placebo (P = 0.06 in the adjusted analysis). Side effects occurred in 68% of the divalproex group vs. 33% of the placebo group (P = 0.03) and were generally rated as mild. This placebo-controlled study, despite some limitations, suggests possible short-term efficacy, tolerability, and safety of divalproex for agitation in dementia and supports further placebo-controlled studies.
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U2 - 10.1097/00019442-200102000-00009
DO - 10.1097/00019442-200102000-00009
M3 - Article
C2 - 11156753
AN - SCOPUS:0035172216
SN - 1064-7481
VL - 9
SP - 58
EP - 66
JO - American Journal of Geriatric Psychiatry
JF - American Journal of Geriatric Psychiatry
IS - 1
ER -