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Original Research

A 3-Month, Randomized, Placebo-Controlled, Neuroleptic Discontinuation Study in 100 People With Dementia: The Neuropsychiatric Inventory Median Cutoff Is a Predictor of Clinical Outcome

Clive G. Ballard, MRCPsych, MD; Alan Thomas, MRCPsych., MD; Jane Fossey, PhD; Lesley Lee, RMN; Robin Jacoby, MD, FRCPsych.; Marisa M. Lana, MRCPsych; Carol Bannister, MRCPsych; Rupert McShane, MD, MRCPsych.; Alan Swann, MRCPsych.; Ed Juszczak, PhD; and John T. O'Brien, MRCPsych, DM

Published: January 1, 2004

Article Abstract

Background: Although few placebo-controlled neuroleptic discontinuation studies have been conducted in people with dementia, such studies are essential to inform key clinical decisions.

Method: A 3-month, double-blind, placebo-controlled, neuroleptic discontinuation study (June 2000 to June 2002) was completed in 100 care-facility residents with probable or possible Alzheimer’s disease (according to National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer’s Disease and Related Disorders Association criteria) who had no severe behavioral disturbances and had been taking neuroleptics for longer than 3 months. The Neuropsychiatric Inventory (NPI) was used to measure changes in behavioral and psychiatric symptoms. Quality of life was evaluated using Dementia Care Mapping.

Results: Eighty-two patients completed the
1-month assessment (36 placebo, 46 active). The number of participants withdrawing overall (N = 14 [30%] placebo, N = 14 [26%] active treatment) and because of exacerbation of behavioral symptoms (N = 6 [13%] placebo, N = 5 [9%] active treatment) was similar in the neuroleptic- and placebo-treated patients. As hypothesized, patients with baseline NPI scores at or below the median (<= 14) had a particularly good outcome, with a significantly greater reduction of agitation in the patients receiving
placebo (Mann-Whitney U test, z = 2.4, p = .018), while patients with higher baseline NPI scores were significantly more likely to develop marked behavioral problems if discontinued from neuroleptics (chi2 = 6.8, p = .009). There was no overall difference in the change of quality of life parameters between groups.

Discussion: A standardized evaluation with an instrument such as the NPI may be a clinical indicator of which people with dementia are likely to benefit from discontinuation of neuroleptic treatment.

Volume: 65

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