Comparative efficacy study of haloperidol, olanzapine and risperidone in delirium

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Abstract

Objective

The objective of the study was to assess the efficacy and safety of second-generation antipsychotics olanzapine and risperidone vs. haloperidol in patients of delirium admitted to medical and surgical wards.

Methods

Prospective follow-up single-blind randomized controlled trials were performed. Consecutive patients with delirium referred to the consultation–liaison psychiatry team were eligible for the study. The study sample comprised 64 patients, with 20 subjects in the haloperidol group, 21 subjects in the risperidone group and 23 subjects in the olanzapine group. A flexible dose regimen (haloperidol −0.25 to 10 mg; risperidone −0.25 to 4 mg; olanzapine −1.25 to 20 mg) was used. Delirium Rating Scale-Revised-98 (DRS-R98) was used as the primary efficacy measure, and mini mental status examination (MMSE) was used as a secondary efficacy measure.

Results

There was no significant difference in mean baseline DRS-R98 severity scores and MMSE scores between the three groups. However, there were a significant reduction in DRS-R98 severity scores and a significant improvement in MMSE scores over the period of 6 days, but there was no difference between the three groups. Four patients in the haloperidol group, six subjects in the risperidone group and two subjects in the olanzapine group experienced some side effects.

Conclusions

Risperidone and olanzapine are as efficacious as haloperidol in the treatment of delirium.

Introduction

Delirium is a common neuropsychiatric disorder among medically compromised patients. It is characterized by disturbance of consciousness, attention, cognition and perception and can also affect emotions, sleep and psychomotor activity [1]. The treatment of patients with delirium involves identifying and treating the etiology of the delirium, ensuring safety and improving the patient's functioning. In terms of pharmacological treatment, antipsychotic medications and benzodiazepines are the commonly used agents. Among the antipsychotics, haloperidol continues to be the most commonly used [2]. However, haloperidol can also lead to extrapyramidal symptoms which are more likely to occur in delirious patients because delirium is more common in elderly and severely medically ill patients. In the last decade or so, many researchers have evaluated the usefulness of second-generation antipsychotics in delirium; however, most of the data are in the form of case reports/case series and open-label trials [3], [4]. Although some randomized controlled trials are available evaluating the role of various atypical antipsychotics in delirium [5], [6], [7], [8], [9], [10], [11], [12], [13], [14], the data are still limited. These trials have compared an antipsychotic agent with haloperidol [5], [6], [7], [8], [10] or two atypical agents [11], [14], and only few trials had placebo-controlled design [8], [12] for treatment of delirium. One trial compared haloperidol with chlorpromazine and lorazepam [9]. In general, these trials have shown that there is no significant difference between the efficacy of haloperidol and atypical antipsychotics in the treatment of delirium. However some of these trials have included only subjects admitted to intensive care units who were mechanically ventilated [13], whereas others have been focused on geriatric population. However, delirium is a heterogeneous disorder, arising due to multiple etiologies, and in our setting is seen more frequently in nonelderly population [15]. Hence, the findings of some of the above studies cannot be generalized to this population. Hence, there is a need to evaluate the effectiveness of atypical antipsychotics in delirium inpatients who are relatively young. This prompted the present randomized controlled trial, which assessed the efficacy and safety of second-generation antipsychotics olanzapine and risperidone vs. haloperidol in patients of delirium admitted to medical and surgical wards.

Section snippets

Approval/consent

The plan of the study was approved by the research and ethics committees of the institute (Post Graduate Institute of Medical Education and Research, Chandigarh, India) where it was conducted. Written informed consent was taken from the patients' primary caregivers prior to randomization. Prior to randomization, the purpose of the study and the pharmacological interventions which are currently available were explained to them. If their patient participates in the trial, they were also told

Results

The mean age of all the three groups was in the mid-40s, and only three subjects in the haloperidol group, two subjects in the risperidone group and 6 subjects in the olanzapine group were 65 years or older. The mean number of years of education varied from 9 to 9.35 years, with slightly higher mean for the risperidone group. Majority of the subjects in all the groups were males. However, no statistically significant difference was noted between the three groups on the above variables (Table 1).

Discussion

Management of delirium involves ensuring safety, improving functioning, identifying and treating the etiology of the delirium and using antipsychotics to control symptoms. Haloperidol continues to be the most commonly used antipsychotic in delirium. However, in recent times, some data have emerged which suggest that atypical antipsychotics may be as efficacious as haloperidol in the treatment of delirium.

The present study was a single-blind randomized controlled trial which evaluated the

Acknowledgments

The study was funded by Institute Research Fund.

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    Conflict of interest: none.

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