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Divalproex Sodium in Nursing Home Residents With Possible or Probable Alzheimer Disease Complicated by Agitation

A Randomized, Controlled Trial

Received January 3, 2005; revised March 29, 2005; accepted March 30, 2005. From the Depts. of Psychiatry (PNT, AP, LJ); Medicine, Neurology, and the Center for Aging and Developmental Biology (PNT), the Univ. of Rochester Medical Center, Rochester, NY; University of California at San Diego, San Diego, CA (RR, RT, LT, KS); Depts. of Psychiatry and the Behavioral Sciences and Neurology, Keck School of Medicine, University of Southern California, Los Angeles, CA (LS); the Dept. of Psychiatry, Medical University of South Carolina, Charleston, SC (JM); and Neurobehavioral Research, Inc., Lawrence, NY (RB). Send correspondence and reprint requests to Pierre Tariot, Monroe Community Hospital, 435 East Henrietta Road, Rochester, NY 14620. e-mail: pierre_tariot{at}urmc.rochester.edu
© 2005 American Association for Geriatric Psychiatry

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.

Key Words: Alzheimer Disease • Outcome Studies • Divalproex Sodium • Nursing Home Patients

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