Sertraline versus small doses of haloperidol in the treatment of agitated behavior in patients with dementia

Agitated behavior is very common among demented patients and it is one of t he main causes of institutionalization of the patients, and of marked distr ess to families and caregivers. In order to evaluate the efficacy and toler ability of the selective serotonin reuptake inhibitor (SSRI) sertraline-hyd rochloride versus small doses of haloperidol for treating agitated behavior s associated with dementia, we performed a randomized, double blind, flexib le dose comparison study of sertraline (25-50 mg/day) versus small doses of haloperidol (1-2 mg/day) in 23 institutionalized demented patients (mean a ge 81.5 +/- 6.7 years) with agitation and behavioral disturbances, accordin g to DSM-IV criteria. Data were collected at start and after 10 weeks of tr eatment by direct observation performed routinely by trained nurses. Agitat ion was evaluated by Cohen-Mansfield agitation inventory (CMAI) and the rat ing scale for extrapyramidal side effects. At start there was no difference in CMAI scores between the two groups of treatment. After taking moderate doses of sertraline and small doses of haloperidol, both groups showed sign ificant improvement in the agitation behaviors (p < 0.05), without signific ant differences between haloperidol and sertraline groups, whereas signific ant differences were observed in the incidence of extrapyramidal symptoms. This study confirms the importance of the SSRIs in the treatment of non-cog nitive symptoms associated with dementia, and, underlining the relative abs ence of side effects, suggests an adequate consideration of this drug befor e initiating a long trial of neuroleptics.