Effect of oxcarbazepine in the treatment of agitation and aggression in severe dementia

Dement Geriatr Cogn Disord. 2009;27(2):155-63. doi: 10.1159/000199236. Epub 2009 Feb 2.


Background/aims: To evaluate the efficacy of oxcarbazepine (OXC) in the treatment of agitation and aggression in patients with Alzheimer's disease, vascular dementia or both.

Methods: This is an 8-week, multicenter, randomized, double-blind, placebo-controlled trial carried out independently of the pharmaceutical industry. Changes in the agitation and aggression subscore of the Neuropsychiatric Inventory (NPI) were the primary outcomes. The secondary out- comes were the changes in the caregivers' total burden scores (measured by the NPI) and changes in the Brief Agitation Rating Scale (BARS).

Results: In total, 103 institutionalized patients at 35 sites were randomized to the trial. After 8 weeks, no statistically significant differences were found between the 2 groups for all outcomes. A trend was observed in favor of the OXC group in the reduction in the scores on the BARS (p = 0.07).

Conclusion: This study found no significant effect of OXC in treatment of agitation and aggression in patients with dementia.

Trial registration: ClinicalTrials.gov NCT00145691.

Publication types

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

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aggression / drug effects*
  • Aggression / psychology*
  • Alzheimer Disease / drug therapy
  • Alzheimer Disease / psychology
  • Anticonvulsants / adverse effects
  • Anticonvulsants / therapeutic use*
  • Carbamazepine / adverse effects
  • Carbamazepine / analogs & derivatives*
  • Carbamazepine / therapeutic use
  • Dementia / complications
  • Dementia / drug therapy*
  • Dementia / psychology*
  • Dementia, Vascular / drug therapy
  • Dementia, Vascular / psychology
  • Double-Blind Method
  • Female
  • Humans
  • Inpatients
  • Male
  • Middle Aged
  • Oxcarbazepine
  • Psychomotor Agitation / drug therapy*
  • Psychomotor Agitation / etiology
  • Psychomotor Agitation / psychology*
  • Treatment Outcome


  • Anticonvulsants
  • Carbamazepine
  • Oxcarbazepine

Associated data

  • ClinicalTrials.gov/NCT00145691