Risperidone in the Treatment of Nonaggressive Agitated Symptoms Related to Dementia: Analysis of 617 Patients in a Randomized, Double-Blind Controlled Trial

Jacobo Mintzer, Medical University of South Carolina, Charleston, SC, USA and Grant Ko, Johnson & Johnson Pharmaceutical Research & Development, LLC, Titusville, NJ, USA.

Objective: The efficacy of atypical antipsychotics in the treatment of aggressive symptoms and psychosis in patients with Alzheimer's disease (AD) and other dementias has been demonstrated. Less information on non-aggressive agitated symptoms has been published. The goal of this study was to evaluate the efficacy of risperidone for non-aggressive agitated symptoms in AD.

Materials and Methods: Data were obtained from a 12-week, randomized, multicenter trial of risperidone (0.5 mg, 1 mg or 2 mg daily) versus placebo (Katz et al, 1999). Subjects were 617 institutionalized patients with dementia. Severity of non-aggressive agitated physical and verbal symptoms (items of the Cohen Mansfield Agitation Inventory) was assessed and analyzed using ANCOVA with factors for treatment, baseline, investigator, and treatment by baseline interactions. These non-aggressive agitated symptoms include pacing and wandering, hiding or hoarding things, repeating sentences or questions, and making strange noises.

Results: Improvements in both physical and verbal non-aggressive symptoms at treatment endpoint were greater in patients receiving 1 or 2 mg/day of risperidone than placebo. Improvements in physical symptoms with 1 or 2 mg/day of risperidone were significant (p￡0.05 and p￡0.01, respectively). Improvement in verbal symptoms with 2 mg/day was significant (p￡0.01).

Conclusion: Risperidone at the reported low doses was found to be efficacious in reducing non-aggressive agitated symptoms related to dementia.

Reference: Katz IR, Jeste DV, Mintzer JE, et al. Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: a randomized, double-blind trial. Risperidone Study Group. J Clin Psychiatry 1999;60:107-115.