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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

Lookup NU author(s): Dr Clive Ballard, Professor Alan ThomasORCiD, Professor John O'Brien


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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 (less than or equal to 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 (chi(2) = 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.

Publication metadata

Author(s): Ballard CG, Thomas A, Fossey J, Lee L, Jacoby R, Lana MM, Bannister C, McShane R, Swann A, Juszczak E, O'Brien JT

Publication type: Article

Publication status: Published

Journal: Journal of Clinical Psychiatry

Year: 2004

Volume: 65

Issue: 1

Pages: 114-119

ISSN (print): 0160-6689

ISSN (electronic): 1555-2101

Publisher: Physicians Postgraduate Press, Inc.


DOI: 10.4088/JCP.v65n0120


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