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ORIGINAL ARTICLE

Comparison of efficacy of haloperidol and olanzapine in the treatment of

delirium
Rajan Jain, Priti Arun, Ajeet Sidana, Atul Sachdev1
Departments of Psychiatry and 1General Medicine, Government Medical College and Hospital, Chandigarh, India

ABSTRACT

Objective: Till date, typical antipsychotic haloperidol is the treatment of choice for delirium. But, due to higher side
effects with haloperidol, newer atypical antipsychotics (e.g., olanzapine) are increasingly being used in the treatment of
delirious patients. The aim of the current research was to study the efficacy and tolerability of haloperidol and olanzapine
in the treatment of delirium.
Materials and Methods: This was an open‑label, randomized controlled study carried out in a tertiary care hospital
at Chandigarh, India. A total of 100 patients admitted in medicine, surgery, and orthopedic wards and diagnosed
as having delirium on Confusion Assessment Method scale were included in the study. Patients were given either
haloperidol (1–4 mg/day either orally or by nasogastric tube) or olanzapine (2.5–10 mg/day either orally or by nasogastric
tube). Severity of delirium and pattern of symptom improvement were assessed by Memorial Delirium Assessment
Scale (MDAS). Extrapyramidal side effects were assessed by Simpson–Angus Scale.
Results: There was an improvement in delirium severity in both groups with treatment. Mean daily dose of haloperidol
and olanzapine used per patient was 2.10 and 5.49 mg, respectively, and the mean duration of treatment in olanzapine
group and haloperidol group was 3.57  days and 3.37  days, respectively. There was no significant difference in the
mean duration of treatment in both groups. At the end of study period, the MDAS scores in olanzapine and haloperidol
groups were 8.43 and 8.00, respectively, and the difference was not significant statistically with P = 0.765. Five patients
experienced drug‑related mild side effects.
Conclusion: Low‑dose haloperidol and olanzapine were equally efficacious and well tolerated in delirium.

Key words: Delirium, efficacy, haloperidol, olanzapine, tolerability

INTRODUCTION activity, and perceptual abnormality due to one or more

Delirium is a complex neuropsychiatric condition common
in hospitalized patients. It is characterized by altered level
of consciousness, inattention, disorientation, disorganized
thinking, altered sleep–wake cycle, altered psychomotor
structural and/or physiological abnormalities directly or
indirectly affecting the brain. Delirium is typically abrupt
in onset and fluctuating in nature.[1] Delirium is associated
with 6%–18% risk of death, increased hospital stay, caregiver
burden, and increased treatment cost.[2,3]

Address for correspondence: Dr. Ajeet Sidana,

Antipsychotics are the mainstay of treatment for delirium except
Department of Psychiatry, Government Medical College for delirium due to alcohol or benzodiazepine withdrawals.[4]
and Hospital, Sector‑32, Chandigarh (UT) ‑ 160 030, India. Haloperidol is the gold standard of treatment.[5] Recent studies
E‑mail: ajeetsidana@hotmail.com
This is an open access article distributed under the terms of the Creative
Access this article online Commons Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows
Quick Response Code others to remix, tweak, and build upon the work non‑commercially, as long as the
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www.indianjpsychiatry.org For reprints contact: reprints@medknow.com

DOI:
How to cite this article: Jain R, Arun P, Sidana A, Sachdev A.
Comparison of efficacy of haloperidol and olanzapine in the
10.4103/psychiatry.IndianJPsychiatry_59_17
treatment of delirium. Indian J Psychiatry 2017;59:451-6.

© 2018 Indian Journal of Psychiatry | Published by Wolters Kluwer - Medknow 451

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Jain, et al.: Haloperidol and olanzapine in delirium
have compared the role of various typical (chlorpromazine)[6]
and atypical antipsychotics (risperidone);[7‑9] olanzapine[10‑16]
and quetiapine[17,18] in delirium.
There have been three single‑agent studies and seven
comparison studies for the use of olanzapine in delirium.[10‑21]
However, the available studies on the use of olanzapine in
delirium had various shortcomings, for example, sample
size was smaller,[12‑16] randomization was not done,[10,12‑15,21]
lack of standard method of assessment, and infrequent
follow‑ups.[10,14,16]
A recent meta‑analysis of 15 studies found that
second‑generation antipsychotics may treat delirium better
than placebo, usual care, or haloperidol.[22]
Furthermore, no study till date has studied the pattern of
various symptom improvement in delirium.
Hence, we planned to conduct a randomized controlled
study on 100 delirious patients to compare the efficacy of
olanzapine and haloperidol in delirium. We also studied
the phenomenology of delirium and pattern of various
symptom improvement with treatment.
MATERIALS AND METHODS
Type of study
This was an open‑label, randomized controlled study.
Randomization was done using a computer‑generated
random number table.
Aims and objectives
Our primary aim was to compare the efficacy and tolerability
of olanzapine and haloperidol in delirium. Our secondary
aim was to study the phenomenology of delirium and
pattern of symptom improvement with treatment.
Patients
The study was done on delirious patients admitted in medicine
emergency ward and patients referred to consultation liaison
services of the Department of Psychiatry, Government Medical
College and Hospital, Chandigarh, India. Data collection was
done from December 2011 to December 2012.
Patients who were above 18  years of age, verbally
responsive, and not having dementia were included in the
study. Patients who were mechanically ventilated, mute,
currently taking antipsychotic drugs due to any reasons,
having alcohol or benzodiazepine withdrawal delirium, or
hypersensitivity to either haloperidol or olanzapine in the
past were excluded from the study.
One hundred and thirty‑two consecutive patients meeting
the Diagnostic and Statistical Manual of Mental Disorders‑IV
(DSM‑IV) criteria for the diagnosis of delirium after detection
452
of delirium using Confusion Assessment Method  (CAM)
were recruited. Thirty‑two patients dropped out of the
study after randomization; due to death, transfer to ICU
and transfer to other hospitals, or discharge against medical
advice. These 32 dropped‑out patients were excluded from
the final analysis. One hundred patients completed the
study and were included in the final analysis.
Assessment method
Each patient’s sociodemographic and clinical variables were
recorded on a pro forma designed for the study. CAM[23] was
used to detect delirium and patients were diagnosed as per
the DSM‑IV criteria for delirium. Phenomenology and delirium
severity were assessed by Memorial Delirium Assessment
Scale (MDAS).[24] Drug‑induced side effects were assessed using
a pro forma specially designed for the study. Simpson–Angus
Scale (SAS)[25] was used to assess extrapyramidal side effects.
Patients were rated systematically with the MDAS as a
measure of delirium severity and phenomenology. Delirium
severity was rated as “mild” delirium reflected by MDAS
score ≤15, “moderate” severity delirium by MDAS scores
of 16–22, and “severe” delirium as MDAS scores of 23–30.
A  score of  ≤10 on MDAS was taken as the indicator of
delirium resolution.[10]
Intervention
Patients were randomized into two groups. Intervention was
done on the basis of a computer‑generated random number
table. One group received atypical antipsychotic olanzapine
and the other group received typical antipsychotic
haloperidol. Drugs were given by enteral route only either
orally or by nasogastric tube. Doses of olanzapine and
haloperidol were used on the basis of delirium severity as
assessed by MDAS scores as shown in Table 1.
Response to the treatment was assessed by improvement
on MDAS scores. Assessment was done every 24 h by the
principal investigator till resolution of delirium. Follow‑up
assessment of each patient was done at the same time of
day at which he/she was first assessed. Pattern of symptom
improvement was noted and compared between both the
groups. Total time taken for the resolution of delirium was
noted and compared.
Statistical analysis
Chi‑square test was used to compare the sociodemographic
profile and variables related to clinical profile (nominal data)
Table 1: Doses of olanzapine and haloperidol used and
Memorial Delirium Assessment Scale scores
MDAS score Olanzapine dose (mg) Haloperidol dose (mg)
10‑15 2.5 1
16‑22 5 2
23 and above 10 4
MDAS – Memorial Delirium Assessment Scale
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Jain, et al.: Haloperidol and olanzapine in delirium

Table 2: Number of patients in which various symptoms of delirium were present and number of patients in which
symptoms improved with treatment
Symptom Number of patients in which Number of patients in which
symptoms were present (n=100) symptoms improved (n=100)
Reduced level of consciousness 94 69
Disorientation 100 66
Short‑term memory impairment 99 84
Impaired digit span 100 87
Reduced ability to maintain and shift attention 100 89
Disorganized thinking 95 84
Perceptual disturbance 49 49
Delusions 29 27
Decreased or increased psychomotor activity 100 89
Sleep‑wake cycle disturbance 98 89

Patients suffering from delirium were recruited (N = 132)
Patients were randomized into two equal groups
One group was given olanzapine (N = 66) Another group was given haloperidol (N = 66)
32 dropped‑out cases, 16 died, 9 were shifted to ICU and
could not be assessed further, and 7  patients were either
transferred to other hospital or got discharged against
medical advice. Totally 100 patients were included in the final
analysis; 47 in olanzapine group and 53 in haloperidol group
as shown in Figure 1.

There was no statistically significant difference in the

19 dropped out (9 died,
5 shifted to ICU, 5 shifted
to another ward/ hospital)
Patients had resolution of delirium (N = 47)
Patients included in the final analysis (N = 100)
Figure 1: Flow Chart
13 dropped out (7 died,
4 shifted to ICU, 2 shifted
to another ward/ hospital)
Patients had resolution of delirium (N = 53)
sociodemographic profile, clinical variable, and biochemical
parameters in olanzapine and haloperidol groups and both
groups were comparable to each other.
Delirium severity
Mean MDAS score at baseline was 18.49 in olanzapine
group and 17.79 in haloperidol group. Both groups were
comparable in the severity of delirium at baseline and the
difference was not significant (P = 0.791).

At the end of the study period, the MDAS scores in olanzapine

in both groups. Data analysis was performed using the SPSS
(version 21) statistical software package for Windows (SPSS
Inc., Chicago, IL, USA). The analyzed data were represented
in percentage and mean. Level of significance was set at
P < 0.05.
The study was registered with the Clinical Trial Registry‑India
CTRI/2016/10/007331.
The confidentiality of the information obtained was
maintained and the principles enunciated in the Declaration
of Helsinki were complied with. Indian Council of Medical
Research’s ethical guidelines for biomedical research on
human subjects were adhered to.[26]
The study was approved by the local Institutional Ethics
Committee.
and haloperidol groups were 8.43 and 8.00, respectively,
and the difference was not significant statistically with
P = 0.765.
Phenomenology of delirium
The various symptoms of delirium in both the groups
were; disorientation, impaired digit span, reduced ability
to shift attention, decreased or increased psychomotor
activity, short term memory impairment, sleep-wake cycle
disturbance, reduced level of consciousness, perceptual
disturbance and delusions as shown in Table 2.
Pattern of symptom improvement
Overall, there was improvement in all the symptoms of
delirium with treatment and at the end point there was no
significant difference between both groups in any of the
symptoms.

RESULTS During the study period, few symptoms improved earlier

in one group than the other. Severity of inattention on
One hundred and thirty‑two patients were recruited day 2 and severity of disorganized thinking on days 2 and
for the study. Thirty‑two patients dropped out; 19 from 3 were significantly lesser in olanzapine group than that
olanzapine group and 13 from haloperidol group. Out of the of haloperidol group  (P  <  0.05). Severity of perceptual

Indian Journal of Psychiatry Volume 59, Issue 4, October-December 2017 453

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Jain, et al.: Haloperidol and olanzapine in delirium
disturbances on day 4 and severity of psychomotor
disturbances on days 3 and 4 were significantly less in
haloperidol group than that of olanzapine group (P < 0.05).
Dose of antipsychotic used
Mean daily dose of olanzapine used was 5.49  mg
(range = 2.5 mg) and mean daily dose of haloperidol was
2.10 mg (range = 1–5 mg). In terms of chlorpromazine
equivalents, mean daily doses of antipsychotics used were
109.8 and 105, respectively, in olanzapine and haloperidol
groups.
Duration of treatment
The mean duration of treatment in olanzapine group and
haloperidol group was 3.57 days and 3.37 days, respectively,
and the difference between two groups was not statistically
significant with P = 0.233.
Drug‑related adverse effects
Totally five patients had drug‑related side effects; two in
olanzapine group and three in haloperidol group. One
patient in olanzapine group had excessive sedation and
one had developed akathisia. All the three patients in
haloperidol group had drug‑induced parkinsonism. Four
out of the five patients were >55 years old and were male.
Side effects were mild in severity and no change in drug
dose and scheduling was required due to these side effects.
No anti‑parkinsonism drug or other drug was given to
counter these side effects. No change in metabolic profile
was observed during the study period.
DISCUSSION
In the present study, impaired attention, disorientation,
and altered psychomotor activity were the most common
symptoms present in delirious patients.
Mean daily doses of olanzapine and haloperidol required
in the study population were 5.49  mg and 2.10  mg,
respectively. Mean daily dose of antipsychotics (olanzapine
and haloperidol) in terms of chlorpromazine equivalents was
109.8 mg and 105 mg, respectively. This is in accordance with
the previous studies where lesser than usual antipsychotic
doses are required to treat delirium. Our study results
are in concordance with the earlier studies where mean
daily doses in the range of 37.5–169  mg chlorpromazine
equivalent are sufficient to treat delirium.[6,10,13,15,17,27]
Mean duration of treatment was calculated as the mean
time taken by each patient from the start of treatment to
resolution of delirium. Mean duration of treatment in our
study was 3.47 ± 0.82 days. Mean duration of treatment
in olanzapine group was 3.57 ± 0.92 days. Mean duration
of treatment in haloperidol group was 3.37 ± 0.71 days.
The results between the two groups were not statistically
454
significant from each other. Our results match with the
previous studies where mean time to improvement was
3.8–4.8 days.[8,13,28,29]
In the current study, there was 54.7% reduction in mean MDAS
scores (54.4% in olanzapine group and 55% in haloperidol
group). The study results correlate with the previous studies
where there was reduction of 7%–70% in various delirium
rating scales over the study period.[6,10,12,13,16,17,28,30]
There was an improvement in all domains of delirium,
i.e., consciousness, attention and concentration, memory,
thinking, psychotic symptoms, psychomotor activity, and
sleep with treatment in both groups. Moreover, there was
no significant difference in the final scores in any domain
between both groups.
However, the earlier improvement of few symptoms
such as impaired attention and disorganized thinking in
one group over the other can be explained in terms of
pharmacodynamic properties of the drugs.
Both inability to maintain and shift attention and disorganized
thinking are cognitive phenomenon. Atypical antipsychotics
such as olanzapine substantially block cortical serotonergic
receptors (5HT2A). Serotonin inhibits the release of dopamine.
Hence, when serotonin is blocked, dopamine concentration
is increased at mesocortical pathway which is associated
with cognition and socialization. However, haloperidol, being
a typical antipsychotic, nonselectively blocks dopamine at
D2 receptors in mesolimbic, mesocortical, and nigrostriatal
pathways. Hence, increase in dopamine at mesocortical pathway
may be responsible for the early and better improvement in
ability to maintain and shift attention and disorganized thinking
in olanzapine group than haloperidol group.[31,32]
Half‑lives of haloperidol and olanzapine are 12–36  h and
21–54  h, respectively. Time taken to reach peak plasma
concentration after oral dose is 1–4  h for haloperidol and
2–6 h for olanzapine. Any drug usually needs up to 5 half‑life
to reach a steady‑state plasma concentration. Steady‑state
concentration is reached within 3–5 days in haloperidol due to
short half‑life and it takes even up to 7 days in case of olanzapine
to reach steady‑state concentration. Effect on psychotic
symptoms  (delusions and hallucinations) and psychomotor
activity depends on effective blockade of dopamine in
mesolimbic and nigrostriatal pathways. Haloperidol attains
steady‑state concentration earlier, so it acts faster and hence
leads to earlier improvement in perceptual and psychomotor
disturbances than that of olanzapine group. Overall, five
patients had minor adverse effects related to antipsychotics (2
out of 47, i.e., 4.25% in olanzapine group and 3 out of 53,
i.e., 5.6% in haloperidol group). Sedation can be explained in
terms of more anticholinergic effects of olanzapine and Extra
Pyramidal Symptoms  (EPS) due to blockage of nigrostriatal
pathway by haloperidol.
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Jain, et al.: Haloperidol and olanzapine in delirium
None of the side effects were of such severe intensity that
required stopping the drugs or any change in the doses of
the drugs. This can be understood in terms of low doses
of antipsychotics used as well as the short duration of
treatment required in the treatment of delirium. Our
results correlate with that of the earlier studies where side
effect prevalence between 0% and 40% has been reported
depending on the drugs used, its dosages, and duration of
treatment of delirium.[6,13,15,28,30,33]
Strengths and limitations of study
It was a randomized controlled study. Randomization was
done using a computer‑generated random number table.
A total of 100 patients were included in the final analysis.
Hence, the number of cases studied was higher than most of
the earlier studies. Active case finding was done in medicine
emergency using CAM. This prevented any bias in the study
sample. Valid scales with high specificity and sensitivity, i.e.,
CAM, MDAS, and SAS were used in the study. Patients were
followed up every 24 h till resolution of delirium.
However, certain limitations need to be considered while
interpreting the results. It was a single‑blind study and
interviewer was not blind to the treatment given. Hence,
it could lead to interviewer bias in the study population.
Placebo arm was not included. Patients who were more
severely ill, unable to speak, mechanically ventilated, and
who could not consume oral medicines were excluded from
the study. This possibly resulted in the inclusion of more
mild‑to‑moderate cases in our study. This possibly resulted
in bias in our results, i.e., higher response rate and less
mean duration of treatment in our study.
CONCLUSION
Overall, patients with delirium responded well to low doses
of both haloperidol and olanzapine. Patients tolerated both
drugs equally well that can be expected due to low mean
daily doses of drugs as well as shorter duration of treatment
required in delirium.
At the end of the study period, there was no significant
difference in response to both drugs in all the domains, i.e.,
consciousness, memory, attention and concentration, thinking,
perception of psychomotor activity, and sleep–wake cycle.
Hence, we can conclude that both olanzapine and
haloperidol can be safely used in the treatment of delirious
patients, and low doses of antipsychotics for short duration
are usually sufficient.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
Indian Journal of Psychiatry Volume 59, Issue 4, October-December 2017
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