EFFICACY AND TOLERABILITY OF CARBAMAZEPINE FOR AGITATION AND AGGRESSION IN DEMENTIA

Objective: The efficacy, safety, and tolerability of carbamazepine in the treatment of agitation and aggression associated with dementia wer e assessed. Method: In a 6-week, randomized, multisite, parallel-group study of 51 nursing home patients with agitation and dementia, indivi dualized doses of carbamazepine were compared with placebo. Except for a physician monitor and a pharmacist, all participants were blind to treatment. The primary outcome measures were the Brief Psychiatric Rat ing Scale (BPRS) and Clinical Global Impression (CGI) global improveme nt rating. Secondary measures included measures of behavior, aggressio n, cognition, functional status, staff time, safety, and tolerability. Intent-to-treat analysis was performed. Results: The modal carbamazep ine dose at 6 weeks was 300 mg/day, and a mean serum level of 5.3 mu g /ml was achieved. The study was terminated after a planned interim ana lysis showed that carbamazepine provided more benefit than did placebo . Over 6 weeks the mean total BPRS score decreased 7.7 points for the carbamazepine group and 0.9 for the placebo group, and the weekly scor es showed a gradual divergence between the two groups. CGI ratings sho wed global improvement in 77% of the patients taking carbamazepine and 21% of those taking placebo. Secondary analyses confirmed that the po sitive changes were due to decreased agitation and aggression. The dru g was generally well tolerated, and no change in cognition or function al status occurred. The perception of staff time needed to manage agit ation showed a decrease for carbamazepine but not placebo. Conclusions : This controlled study showed significant short-term efficacy of carb amazepine for agitation with generally goon safety and tolerability.