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


METHODS
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 (< or = 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.


CONCLUSIONS
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.
Ballard
Clive G
CG
Wolfson Research Centre, Newcastle General Hospital, Newcastle, UK. c.g.ballard@ncl.ac.uk
Thomas
Alan
A
Fossey
Jane
J
Lee
Lesley
L
Jacoby
Robin
R
Lana
Marisa M
MM
Bannister
Carol
C
McShane
Rupert
R
Swann
Alan
A
Juszczak
Ed
E
O'Brien
John T
JT
D000368:Aged; D000369:Aged, 80 and over; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000494:pharmacology; D003704:Dementia / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D010352:Patient Dropouts; D010919:Placebos; D011237:Predictive Value of Tests; D011379:Prognosis; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics; D011788:Quality of Life; D016896:Treatment Outcome; D028761:Withholding Treatment
D014150:Antipsychotic Agents; D010919:Placebos