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A Controlled, Double-blind Study

Jiska Cohen-Mansfield, PhD; Steven Lipson, MD; Perla Werner, PhD; Nathan Billig, MD; Levi Taylor, PhD; Raymond Woosley, MD, PhD

Arch Intern Med. 1999;159:1733-1740.

Background  Ongoing regimens of haloperidol, thioridazine, and lorazepam are commonly administered to manage behavior problems in nursing home residents. Nevertheless, there is controversy over whether periodic drug withdrawal should be attempted when those medications are prescribed. This study addressed that issue by examining the effects of discontinuing treatment with haloperidol, thioridazine, and lorazepam among residents of a large suburban nursing home.

Methods  In a double-blind, crossover study, half of 58 nursing home residents (43 women and 15 men with a mean age of 86 years) continued to take the psychotropic medication they had been prescribed, whereas the other half were tapered to placebo. After 6 weeks of taking placebo or original drug, patients were tapered to the reverse schedule and remained on it for 6 weeks. Assessments included informant ratings by the nursing staff who completed the Brief Psychiatric Rating Scale and the Cohen-Mansfield Agitation Inventory.

Results  Analyses comparing residents taking placebo to those taking medication after completion of the first phase showed no impact of drug therapy discontinuation on their behavior. Similarly, using the crossover design to compare residents' behaviors while taking placebo vs taking drugs, withdrawal of medication had no impact on Cohen-Mansfield Agitation Inventory or Brief Psychiatric Rating Scale scores.

Conclusions  Results of this work suggest that long-term use of haloperidol, thioridazine, and lorazepam in nursing homes to manage agitation should be closely monitored for their efficacy. Furthermore, routine attempts at drug withdrawal should be considered for most residents taking psychotropic medication.

From the Research Institute of the Hebrew Home of Greater Washington, Rockville, Md (Drs Cohen-Mansfield, Lipson, Werner, and Taylor) and Georgetown University Medical Center, Washington, DC (Drs Cohen-Mansfield, Billig, and Woosley). Dr Werner is currently with the University of Haifa, Haifa, Israel.

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