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Regular Article |
Received May 3, 2000; revised June 2, 2000; accepted June 29, 2000. From the Department of Psychiatry and Program in Neurobehavioral Therapeutics, University of Rochester Medical Center, Rochester, New York. Address correspondence to Dr. Porsteinsson, University of Rochester Medical Center, Program in Neurobehavioral Therapeutics, Monroe Community Hospital, 435 E. Henrietta Rd., Rochester, NY 14620; e-mail: antonp{at}frontiernet.net
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.
Key Words: Dementias (general) • Agitation • Divalproex Sodium
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