REGULAR ARTICLES

Discontinuation of
Antipsychotics in Nursing
Home Patients With Dementia
GaryJ. Horwitz, M.D., Pierre N. Tarlot, M.D.,
Karen Mead, M.D., Christopher Cox, Ph.D.
The authors assessed tbe consequences of Slopping antipsychotic medication in nursing bome patients with dementia, as mandated by federal regulations (OBHA 87).
They studied three patient groups: 1) a group (clinical
judgnzent") whose antipsycbotics were discontinued at
tbediscretion oftbeirpbysicians; 2) agroup (rempirical")
with mandated cessation ofanlipsycbolics in tbe -facility;
and 3) a comparison group of patients not receiving
medication. Tbe primary outcome measure was tbe necessity to resume antipsychotic or other psychotropic
medication {failure? Also, assessments of behavior,
function, neurologic status, and cognition were performed by blind raters. Thefailure rate in tbe empirical
withdrawal group was 50%, 10 limes tbat ofthe clinical
judgnlent group. Amongfai/ures, tbe most striking result
was increased verbalandphysicalaggression. Nofailures
occurred in tbe comparison group. There were no benefits
of antipsychotic withdrawal in terms of neurological
performance, functional status, or cognition. (American
Journal of Geriatric Psychiatry 1995; 3:290-299)

C

ross-sectio nal studies of the prevalence of mental disorders among
residents of long-term care facilities have
demonstrated that approximately 70%
suffer from dementia or a similar serious
organic mental disorder. 1-1 Of these,
approximately 90% have behavior problems. 1•2•i The treatment of these behav-

ioral disturbances ideally entails identifi·
cation and reversal of specific physical,
environmental, social, and psychiatric
precipltants. 'i When these steps fall, symptomatic phannacothcrapy is usually considered.
Over half of nursing home patients
receive psychotropic medications, and

Rc."CCh'edjunc 13, 1994; n.."iscd Non:mber-i. 1994; accepted November 21. 1994. From the Dcpanment of
Ps}'chiatr}·. Uni\-cf5il)' of Rochcslcr Ml."dicalCenren and St. John's Nursing Horne, AddR."SS correspondence to
Dr. Horwitz, Mental Hcahh Team. SLJohn's Home. 150 Highbnd A\"Cnuc. Rochester, NY 14620.
Copyright 0 1995 American ~tion for Geriatric Ps)"Chiauy
290

VOLUME 3 • NUMBER4 • FAll 1995

Horwitz et 01.

antlpsychottcs arc used most frequently
for behavior disturbances.6 •7 Available
data indicate only a modest response
rate, however, and toxicity is common. 7 - IO Concern about nonspecific use
of psychotherapeutic medications in
nursing homes led to legislative attempts
at a remedy. In 1987, Congress passed
laws known as the Nursing Home Refonn
Amendments of the Omnibus Budget
Reconciliation Act of 1987 (OBRA 87)9 1•
which included regulations concerning a
variety ofclinical issues. including the use
of medications. Specifically, the regulations stated that each resident's drug regimen must be free from unnecessary
drugs, including anti psychotics. II Where
antlpsychotlcs were used in patients with
dementia, gradual dose reduction up to
and including discontinuation was to be
attempted twice in a year; A subsequent
return of behavioral symptoms for which
the medication was initially prescribed
could result in resumption of treatment.
Preliminary indications suggest that
the OBRA regulations. as well as the
development of broad-based educational
programs designed to decrease medtcation
usc, have had a significant impact. 12-15 The
question remains, however: What are the
risks and benefits of universal withdrawal
of anti psychotics in this population? In
view of the limited data available and the
requirements in OBRA, we used the historic opportunity to study the implementation of regulations in one nursing home to
determine how frequently patients with dementia, receiving steady doses of antipsychotic medlcation, fail to maintain clinical
stability after discontinuation of the medication.

METHODS
SettingIDesign

St. John's Home is a 471-bed facility
providing all levels of nursing home care.
TilE AMF.R1CAN JOURNAl. OF GERIATRICPSYCHIATRY

Most patients have an on-site attending
internist. The facility has also had on-site
psychiatric consultation services for many
years. The study entailed varying levels of
observation of three patient groups at the
time DORA 87 was implemented at the
facility.
The first group ("clinical judgment"
group) consisted or all (II = 21) patients
in this nursing home with dementia receiving antlpsychotics, who wert: judged
by their attending physicians to be appropriate to withdraw from antipsychotics
per the nL~V DORArequirements. An educational inscrvicc oral presentation 00
DORA87 and the use of psychotropics in
the nursing home was provided to the
attending physicians, but no other effort
was made to influence their decisions or
specify clinical criteria for patients to be
withdrawn from medication. The rate of
failures during a 6-month period after
withdrawal (in 1990-1991) was documented for this group. The term "failure"
was applied to the decision made by the
patient's attending physician (without input by the mental health service) to
resume the antipsychotic medication, or
initiate a different psychotropic, for the
same behavioral symptoms.
The second group ("'empirical withdraWal" group) was studied 1 year later. It
consisted of all patients with dementia
still on antipsychotics in the facility (n =
26), who wen: withdrawn without clinical
judgment exercised by the attending physician. After initial assessments were performed, the medication dose was
reduced by 50% for 1 week, by another
50% for 1 week, and then discontinued.
The patients were then observed on a
regular basis until endpoint was reached,
defined as time of failure or 6 months,
whichever came first. Detailed and repeated observations of behavioral, functional, neurologic, and cognitive status
were made in order to characterize the
consequences of antipsychotic withdrawal as well as define possible predic291

Discontinuation ofAntipsycbotics
tors of failure to be examined retrospecti\"cl)~

A "comparison" group of six nursing
home patients with dementia, not receiving antipsychoncs, was observed longitudinally for 6 months in a detailed fashion
similar to the second group. This group
was used chiefly to help mask the design.

Subjects

The clinical judgment group consisted of 21 patients with a chan diagnosis of dementia by DSM-III-R criteria. 16
'Iwefve patients met criteria for probable
Alzheimer's disease (AD). five for multiinfarct disease, and the remainder for
nonspecific dementias (II 4). The average age was 82.7 years, 18 patients (86%)
were women; there was one AfricanAmerican; they had recelved an average of
9.6 years of education. Nine subjects received haloperidol (average dose = 1.0
mg/d); five received thioridazine (average
dose = 32 mg/dj ; two received
thiothixenc (average dose = 1.5 mg/d):
two received perphcnazine (average dose
= 1.5 rng/d) , and one received molindone (dosage unknown). With regard to
the major medical diagnoses requiring active treatment, 14 had diagnoses of
atherosclerotic and/or hypertensive cardiovascular disease; five had diabetes
mellitus; two had seizures.
.
The empirical withdrawal group consisted of all remaining subjects with a
diagnosis of dementia by DSM-III-R1(. criteria receiving antipsychotics (II = 26).
Eighteen met criteria for probable AD, six
for multi-infarct dementia, and two for
unspecified dementias, ThL~ group included the only "failure" from the clinical
judgment group, permitted in an effort to
maximize the sample size, given the small
number of cases in the facility. The average age was 87.5 years; 20 (77%) were
women; all were white; they had completed an average of 9.1 years of education. A psychiatrist (GH) confirmed that

=

292

no subject had shown clinically significant change in behavior over the preceding 3 months. Eleven patients received
thioridazine (average dose = 33 mg/d);
12 received haloperidol (average dose =
1.3 mg/d); two received pcrphenazine (4
mg/d and 12 mg/d, respectively); and one
received trifluoperazine 4 mg/d, Six subjects had active psychotic symptoms at
baseline. and 21 were physically and/or
verbally aggressive. Eighteen subjects had
atherosclerotic or hypertensive cardlovascular disease, five had diabetes mellitus,
and one had cancer.
The comparison group consisted of
six patients with dementia by DSM-III-R
criteria I(t who were not receiving an tipsychoties. They were a convenience sample
selected to match the other groups demographically. Four met criteria for probable AD. one for multi-infarct disease. and
one for nonspecific dementia. Their average age was 84 years; all were white
women; they had completed an average
of 10.0 years of education. One control
subject had psychotic symptoms at
baseline, and five were ph}'SicaJlyand/or
verbally aggressive. Three had atherosclerotic cardiovascular disease as the major medical diagnosis requiring active
treatment, and one had ulcers. The three
groups were generally similar in terms of
basic demographic features, and similar
to behaviorally disturbed dementia patients described elscwhere. I - ;\
Outcome 1\leasures
Failure in the clinical judgment
group was determined by review of pharmacy records. Failure in the other two
groups was detennined by the patient's
care team. A variety of measures was used
to characterize behavioral, functional,
neurologic, and cognlttve status in the
second and third patient groups throughout the study. including at baseline. ThL'Se
were performed by trained raters who
had no knowledge of the number or tdenVOl.UME

3 • NUMBER·j • FAIJ. 1995

Horwitz et al:
tily of control cases or of the design. In
the case of behavioral or functional ratings, the "follow-up," or final rating, consisted ofthe last scheduled rating prior to
failure, or the 6-rnonth evaluation. In the
case of neurological and cognitive assessments, the follow-up rating was performed at 6 months or time of failure.
The Overt Aggressio" Scale ofYudofsky et al, 17 was used to assess aggressive
features. It was completed by the patient's nurse for all shifts, every day. For
purposes of analysis, the average scores
for 14 days prior to the times of interest
were used: the 2 weeks prior to first reducing the antipsychotic dose (initial),
and the 2 weeks prior to endpoint (follow-up).
Six items from the Sandoz Clinical
Assessment Geriatric (SCAG;Iii self-care,
emotional lability, irritability, bothersameness, uncooperatlveness, and overall impression) were rated from 0 (none)
to 7 (severe) and were used to assess
other aspects of behavior. These items
were rated at baseline (initial) and then at
2-week intervals until endpoint (followup) bya psychiatric nurse-specialist based
on observations, review of selected portions of the chart, and interviews of staff
without reference to current treatment.

Psycbotic symptoms.

The psychiatric
nurse-specialist determined the presence
of paranoia, delusions, or hallucinations
and rated these psychotic symptoms from
o (none) to 7 (severe) at baseline and
then at 2-wcek intervals until endpoint
(follow-up).

Punctionat status. This measurement
was determined as specified in the Minimum Data Set Plus (MDS+)19 ofthe New
York State Department ofHealth. Self-performance ofactivities ofdaily living (ADt)
was scored on a scale of 0-4, and ADts
requiring that support be provided were
scored on a scale of 0-3 (higher scores
indicated need for more assistance). The
THE AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY

specific items rated by the nurse-specialist
were bed mobility, transfer, locomotion,
personal hygiene, dressing, eating, and
toilet use. This rating was performed at
baseline and at endpoint.

Neurologic status.

This rating was
done by a board-certified neurologist
(KM) before withdrawal and at endpoint,
using the scale for extrapyramidal side
effects (EPS) devised by Simpson and AnguS,20 the Quantlfled Neurologic Exam
(QNE) of Folstcin,z· and the Abnormal
Involuntary Movement Scale (AIMS).21
We also report the "severity" subscale of
the AIMS.

Mini-MenIal Stale Bxam (MMSE).2;\ This
assessment was completed by the same
neurologist and was used to assess cogni-

tive function. Neurologic scales and the
MMSE were performed at baseline and
endpoint.
Several clinical characteristics were
identified a priori as possible predictors
of failure and recorded as present or absent at baseline: risk factors for cerebrovascular disease, other neurological
problems, sensory impairment, prior alcohol abuse, use of centrally active medications, prior history of depression or
psychosis, or severe language impairment. Othcr variables of potential interest (e.g., intercurrent illness, other
medications, major environmental
change, etc.) were not recorded systematically.
Statistical Analysis

Data management and analysis were
performed in collaboration with the Department of Biostatistics at the University
of Rochester. A comparison of characteristics ofsubjects who "failed" vs, those
who "completed" the study (that is, those
who did not need to be back on psychotropic medications) were performed by
r-test, Confidence interva.ls were estab293

Discontinuation ofAntipSJ'cbolics
lished for the main outcome variable,
which was failure rate. The failure rates
for the clinical judgment group and the
empirical withdrawal group were compared by means of Fisher's exact tests,
Failures and cornpleters were compared
longitudinally for differences in SCAG114
items, aggression scores, psychotic symptoms, and functional and neurologic
scores, using a two-way repeated-mens..
UR:S analysis of variance (ANOVA).2" For
the ANOV~ the between-subjects factor
was grouping according to whether they
were completers or failures, and the
within-subject factor was time, because
observations were repeated. The number
of observations (levels) vary from one
measurement to another. The Greenhouse-Gelsser correction to degrees of
freedom was used in all analyses. Residuals wen: also examined as a check on the
assumption of normally distributed errors with constant variance. Finall)~ baseFIGURE 1.

line clinical characteristics of failures and

completers were compared using Fisher's
exact test.

RESULTS
Only one patient out of 21 in the clinical
judgment group failed in the 6 months
after discontinuation. Thirteen (50%) of
the 26 patients whose antipsychotics were
discontinued independent of clinical
judgment according to the OBRArequirement (empirical withdrawal group) failed.
The 95% confidence interval indicates
that the true failure rate is between 30%
and 70%. The failure rates in the groups
were statistically different (P 0.001.
Fisher's exact test, two-tailed). The lime
course ofobserved failures can be seen in
the survival curve in Figure 1, showing
that morc than half the failures occurred
in the first 6 weeks. No failures occurred

=

PatienL'i not requiring resumption of psychotropic medication for treatment of
behavior problems o,,-er time

100
90
80
70

j
fft

60

50
40
30
20
10

o

10

20

30

40

50

fiO 70

80

90 100 110 120 130 140 150 160 170 180 190

Days

VOI.UME 3

• NUMBER" • FAU. 1995

Horwitz et al.

among the six comparison group subjects.
Turning now to the patterns in outcome measures among those who failed
in the empirical withdrawal group, Table
1 summarizes the ANaVA on outcome
measures, comparing completers with
failures (i.e., looking at the effects of
group alone, the effect oftime alone, and
group-by-time interaction). There was a
highly significant worsening of verbal aggression level in those who failed (P =
0.008) compared with eompleters. Failures also had a significant increase in
physical aggression (P = 0.04). Figure 2,
showing total aggression scores, depicts
this phenomenon. In some patients,
worsening of aggression became evident
even during the medication taper. Compieters and failures showed equal deterioration in functional status and
cognition over the period of observation.
The outcome on neurological measFIGURE 2.

ures in the empirical withdrawal group is
also summarized in Table 1. There were
no differences between completers and
failures nor were there diJferential rates
of change between these groups over
time; all showed a statistically si~cant
increase in their EPS20 and QNE 1 scores
that were ofminimal clinical significance.
22
No differences were seen in the AlMS
score though there was a trend toward
increased severity scores in all patients.
Several comparisons were performed
of completers and failures at baseline.
The mean age offailures was 89 years (11
women and 2 men); the mean age of
completers was 86 years (9 women and 4
men INS]). All behavioral and neurological measures were examined: the groups
differed only on the measure of verbal
aggression, which was higher in the failure group (P = 0.04 by r-test). There
was a possible trend toward increased
SCAG18 scores in the failure group at

Mean ( :t SO) total Overt Aggression Scale1? SCORS ofcoDlrolsubjects. comp1elen,
and failed subjects at baseline (inilial) and foDow-up (DO~14 = avenge scale score
for the 14 days prior to endpoint)

o Control

• Completers
a Failures

0.50

e

8

UJ
c
o

0.40

0.30

-=
!!

CD

~

0.20

Cii

;2

0.10

0.00

Initial

TIlE AMERICAN JOURNAL Of GERIATRIC PSYCHIATRY

DOS.14

295

Discontinuation ojAlllipSJ1cbotics
baseline (P = 0.13 by r-test). The mean
doses of thioridazine in the completers
and failures was compared and was
higher (50 mg \'S. 18.3 mg) in the failure
group. The opposite trend was seen for
haloperidol: completers had a higher
dose at the start (1.6 mg vs. 1.0 mg). None
of the clinical variables identified a priori
as possible predictors of failure were as-sociated with increased risk of failure.
No statistically significant differences
were found in outcomes of behavioral
and ncurological measures between the
empirical withdrawal group and the
comparison group of six patients with
dementia who were not on an antipsychotic. All deteriorated in function and
showed worsening of EPS2U scores over
time.

DISCUSSION
U'hen medications were discontinued
independent ofclinical judgment. the failTABLE I.

ure rate (i.c., the rate at which antipsychotlcs or psycho tropics needed to be
resumed for behavior problems) was
50%, 10 times higher than the rate observed when the decision to stop an antipsychotic was made by the clinician. Most
failures occurred within the first 6 weeks.
By contrast, none of the small group of
patients who were not receiving antipsychotlcs had to be placed on medication
during this period.
The most salient characteristic of the
failure group was the increase in m(."'3S·
ures of verbal and physical aggression
compared with the completers; these features may prove to be partial predictors of
success or failure ofwithdrawal in similar
patients. The increase in these scores was
consistent with observations indcpendent of the study. which documented
a marked and sustained increase in incident reports of aggression among the
residents in our facility after implementation of OORA 87 regulations. The doubling of physical aggression scores in the

Initial and roDow-up values for functional. behavioral, cognitive. and neurologic measures
for complcte1"5and failed patients. mean ± SD
Comnlclrnt

Initial

FoUowUp

2.2 ± O.9S
2.2 ± 0.91
2.8: 1.0
7.1 ::7.3
1.21: 0.52

2.-i :0.80
2.4:: 0.73
2.6:: 0.8
6.0:7.0
1.41 :0.58

Initial

Failures
FollowUp

P

Group

Group

TIme

x TIme

0.31
0.31)

O.cJ(Hl-j
O.OOOS

0.31)
0.32

MDS+

~'MSF.
~1'ch()tic

1.8 :0.i8
t.8:tO.73
;\.6::0.9
1)5:7,9
1.30: O.'j.j

2.1:: 0.59
2.1:: 2.1
3.7: 0.7
3.9:7.2
1.52 ± 0.c12

05·i
0.62

O.ICI:: 0.19

0.12 :0.19 OA3: 0.54

n.70 ± O.l19

o.rn e U.16

0.07 ± 0.10 0.15 ± 0.27

1.13 :0.38
I,06:!:OA7
0.58: 0.79

1.18 ± D.·in l.o-i:051
I.08:0....j U.SS :0.31
0.83:: 1.0 0.38: 0.6S

Sc:lr·p~-rf()nn3nt:'C

A()J.Suppul1
S(J\{i hems

:lAAfl."Ssion
foPS

QNF.
AIMSS(,."\"Crity

=

n.')1
O.O.j

O.-il

0.08

0.67
0.98

nos

CUM

O.OOS

0.28 ± 0.36

0.2i

0.18

OJH

1.21 ± 0..18
0.96 ± 0.33
054: 0.78

0.87
0.30
It44

0.047
O.cH
0.59

0.26
0.16

s)mptnms
Verbiil
3AAfl."S."iiun
IJh)'!iical

O.O().j

0.('"

=

Nole: I~ \';llucs (RIm 1\\"0-\\';1\· ANOVA. MllS+
items (R1m Minimum Data Sct Plus. 19 ADI. AClhitk"5 of
Dail)· U,·ing scale. saG = ~ndoz Clinical A."qos...;ment Geriatric. IN MMSF. = Mini·Mental State f.JC)m. 23
AAAf'."S~ion measures were based on the Overt A~'iion SaJe. Ii' EPS = f.xtI':1p}Tamid:aJ Side F.fTl"ClS.20
QNH = Quaruifled Ncunllogic F.xam.2 1 AIMS = t\bnonnalln\"OlunuI)· Mm"Cmcnt Sc:11c. 22

2%

\,OI.UMF.3· NUMBER 4 • FAIJ.I9lJ5

Honoits: et 0/.

failure group suggests a possible explanation for the increase in such incidents. On
the other hand. there wa.. nota significant
s
difference over time between failures and
completers in other measures ofbehavior
or psychotic features.
The hoped-for beneficial effects of
withdrawing antipsychotic medication
wen: not seen in this sample. All groups
showed increasing extrapyramidal dysfunction and deteriorating neurologic
status with time. This is consistent with
the observations of Soin inen et al.,2'"who
found that extrapyramidal dysfunction
progressed in another group of patients
with dementia observed over time. Likewise. no Improvements in ADUi and selfcare were observed. to the contrary there
were erosions in these areas, These findings validate the measures used in the
study because we would expect consistent decline in these domains in a progressive neurologic disease,
The lack of improvement in
neurologic and functional parameters in
this sample may relate to the low doses
that were being uscd at the start orthis
study. It remains possible that patients at
higher doses would show improvement
after reduction or discontinuation of antipsychotics. It could also be argued that
the withdrawal schedule was too rapid
and that the rate of failures actually resulted from withdrawal phenomena. Although this idea remains a consideration,
the observations that the antipsychotic
doses were extremely low to begin with,
and that some changes were seen even
during the taper; suggest that prolonging
the withdrawal may have had little impact
in our patients.
Our findings appear to differ from
those of Thapa et al, l5 They studied the
effects of a randomized trial of an educational program designed to reduce antipychotic usc, and reported no worsening
ofbehavior problems, cognitive status, or
functional status among patients selected
for discontinuation by their physicians. In

TimAMERICAN JOURNAL OF GERlAmlC PSYCHlAmV

effect, this was analogous to our clinical
judgment group. The studies have similar
results regarding the consequences ofexercising clinical judgment, and both indicate efficacy of educational programs.
The guidelines used by Thapa et al., I')
however, excluded patients with psychosis or history ofviolence, leaving open the
question of results if those patients had
been withdrawn. Because the application
of OBRA regulations in New York State
requires repeated efforts to withdraw psychotropics in all patients, this withdrawal
is the phenomenon that we examined
most closely. 'Iwenty-one of the 26 subjects in the empirical withdrawal group
experienced psychotic and/or aggressive
symptoms at baseline, indicating that our
sample was likely quite different from the
patients studied by Thapa et al. We
believe that even in those institutions
initially using higher doses or less sophisticated psychiatric management, repeated efforts at withdrawal would
eventually result in a similar starting
point and failure rates presumably similar
to those found in our empirical withdrawal group.
Several methodological issues should
be taken into account when considering
this report. There were heterogenous dementia diagnoses in each group, a fact
that may have contributed to variability of
response to treatment or withdrawal, Although the patients studied shared
demographic similarities with other samples reponed in the literature, there
could be bias hidden in the relatively
small sample size. Furthermore, this institution is atypical in that there is an active
mental health program there. It could be
argued that the use of anti psychotics in
general would be either less or more specific because of this service. A consequence might be an increased failure rate
in the empirical withdrawal group, which
was in effect enriched with cases who
needed these medications. Random assignment was not used in the decision to
297

Discontlnuation ofAliliPSJ'chotics
withdraw antipsychotics from subjects.
nor wen: patients, physicians. or nurses
blinded. because this was a historically
opportune naturalistic study ofthe implementation of a regulation requiring this
intervention, rather than a clinical trial. A
surveillance bias may have Inflated the
apparent failure rate in the empirical
withdrawal group compared with the
clinical judgment group. The latter group
was not monitored closely (e.g., with behavioral measures) by the behavioral
rater, Although there was no interaction
between the rater and the patient's physicians, the closer scrutiny might have
made the physicians more aware of behavioral deterioration and. hence, of the
possible need for resumption of psychotropic medication.
Finally.the comparison group ofsubjects not receiving antipsychotics was not
a true "control" group because these patients were not taking anttpsychotics at
the stan of the study, This group was not
used to address the primary question of
how failure rates differed in the two other
groups; rather, it was used chiefly to help
mask the study for the raters and to help
confirm the validlty of the ratings that
were selected. It is likely that we would
have seen incidental behavior problems

in this group if a true control sample had
been used.
Despite these limitations. the study
suggests that in thc short term. clinicians
in a setting such as this were reasonably
accurate in judging the consequences of
anttpsychottc withdrawal in patients with
dementia. Wholesale withdrawal ofantipsychotlc thcrapy, independent of clinical
judgment.. resulted in a high failure rate
(resumption of antlpsychotics) within 6
months. Expected or desired improvement in functional. cognitlve, or neurological status \\':IS not observed. These
findings suggest that further studies of
antipsychotic withdrawal are in order and
that empirical findings may be valuable in
guiding development and implementation of clinical regulations.

Carol Plank, R.N., AI.S., performed ratillgs for the study.
7bis work was presented at tbe Setentb Annual Aleetillg ofthe American As·
sociation for Geriatric Psychiatry,
Tampa, FI., February 199-1.

The work 'was supported bJ' grants
from the Nell' York State Department of
Health, NIAIH(JIIH-1038/), and NIA (AG086(5).

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