OBJECTIVE: To determine the effects of carbamazepine versus placebo on ratings of behavior in agitated nursing home patients with dementia. DESIGN: Nonrandomized, placebo-controlled, crossover trial conducted in 25 patients in two nursing homes. INTERVENTION: Carbamazepine and placebo were administered during two 5-week periods separated by a 2-week washout. The carbamazepine dose was determined for each patient by a nonblinded physician who did not participate in ratings (modal dose 300 mg/day). MEASUREMENTS: The primary outcome measures were Brief Psychiatric Rating Scale scores and Clinical Global Impression of Change, rated by blind observers. Secondary measures of behavior, adversity, cognition, and functional status were also included. MAIN RESULTS:Median total Brief Psychiatric Rating Scale score decreased 7 points on carbamazepine versus 3 on placebo (P = 0.03). Sixteen subjects were rated as improved globally on carbamazepine versus four on placebo (P = 0.001). Secondary measures of behavior showed similar changes at significant or suggestive (P < 0.10) levels. One subject developed carbamazepine-induced tics, and one died with a pneumonia. There was minimal other adversity. CONCLUSION: This preliminary study suggests that carbamazepine in low doses can reduce agitated behaviors in some patients, with limited adversity resulting. Further research is required to confirm and extend this finding before it can be considered routine clinical practice.
RCT Entities:
OBJECTIVE: To determine the effects of carbamazepine versus placebo on ratings of behavior in agitated nursing home patients with dementia. DESIGN: Nonrandomized, placebo-controlled, crossover trial conducted in 25 patients in two nursing homes. INTERVENTION: Carbamazepine and placebo were administered during two 5-week periods separated by a 2-week washout. The carbamazepine dose was determined for each patient by a nonblinded physician who did not participate in ratings (modal dose 300 mg/day). MEASUREMENTS: The primary outcome measures were Brief Psychiatric Rating Scale scores and Clinical Global Impression of Change, rated by blind observers. Secondary measures of behavior, adversity, cognition, and functional status were also included. MAIN RESULTS: Median total Brief Psychiatric Rating Scale score decreased 7 points on carbamazepine versus 3 on placebo (P = 0.03). Sixteen subjects were rated as improved globally on carbamazepine versus four on placebo (P = 0.001). Secondary measures of behavior showed similar changes at significant or suggestive (P < 0.10) levels. One subject developed carbamazepine-induced tics, and one died with a pneumonia. There was minimal other adversity. CONCLUSION: This preliminary study suggests that carbamazepine in low doses can reduce agitated behaviors in some patients, with limited adversity resulting. Further research is required to confirm and extend this finding before it can be considered routine clinical practice.
Authors: Benedikt Amann; Johannes Pantel; Heinz Grunze; Eduard Vieta; Francesc Colom; Ana Gonzalez-Pinto; Dieter Naber; Harald Hampel Journal: Clin Pract Epidemiol Ment Health Date: 2009-06-16