A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF THIOTHIXENE IN AGITATED, DEMENTED NURSING-HOME PATIENTS

The therapeutic efficacy of thiothixene in the treatment of behaviorally agitated dementia nursing home patients was studied in a double-blind, randomized, placebo-controlled clinical trial. Thirty-three subjects were randomized for thiothixene (dose range: 0.25-18 mg) or placebo treatment over an 11-week period, followed by a 6-week crossover period to assess for return of symptoms in the group crossed over to placebo and further improvement in the group crossed over to thiothixene. Thiothixene was significantly more effective than placebo in the reduction of agitation at the end of 11 weeks of treatment. Symptoms tended to return after discontinuation. There were no significant changes in the Mini-Mental State Examination (MMSE) or Activities of Daily Living (ADLs) and no significant differences in side-effects. Two placebo-treated patients died, and two patients died after being crossed over from thiothixene to placebo. The results suggest the efficacy of low doses of thiothixene for well-defined agitation in specifically selected demented nursing home patients.