Placebo-controlled study of divalproex sodium for agitation in dementia

Am J Geriatr Psychiatry. 2001 Winter;9(1):58-66.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Analysis of Variance
  • Antimanic Agents / administration & dosage*
  • Antimanic Agents / pharmacology
  • Dementia / complications
  • Dementia / drug therapy*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Psychomotor Agitation / drug therapy*
  • Psychomotor Agitation / etiology
  • Regression Analysis
  • Statistics, Nonparametric
  • Valproic Acid / administration & dosage*
  • Valproic Acid / pharmacology


  • Antimanic Agents
  • Valproic Acid