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Psychosomatics 47:385-391, October 2006
doi: 10.1176/appi.psy.47.5.385
© 2006 Academy of Psychosomatic Medicine
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Aripiprazole in the Treatment of Delirium

David A. Straker, D.O., Peter A. Shapiro, M.D., and Philip R. Muskin, M.D.

Received May 12, 2005; revised September 5, 2005; accepted October 4, 2005. From the Dept. of Consultation–Liaison Psychiatry at New York Presbyterian Hospital, and the Columbia Univ. Medical Center. Address correspondence and reprint requests to Dr. David Straker, 850 Park Ave., Suite 1E, New York, NY 10021. e-mail: nyrpsychdoc{at}aol.com; das2115@columbia.edu


  ABSTRACT

 
TOP
 ABSTRACT
INTRODUCTION
 METHOD
 RESULTS
 DISCUSSION
 REFERENCES
 
Antipsychotic drugs are the primary treatment for symptoms of delirium, but their side effects can be problematic. Treatment of delirium with aripiprazole has yet to be evaluated. The authors report on 14 patients with delirium treated with aripiprazole. Twelve patients had a ≥50% reduction in Delirium Rating Scale, Revised–98 scores, and 13 showed improvement on Clinical Global Impression scale scores. There was a low rate of adverse side effects. Aripiprazole may be an appropriate first-line agent for the treatment of delirium because of its minimal effect on QTc interval, weight, lipids, and glucose levels. Controlled comparison studies should be performed to confirm this impression.


  INTRODUCTION

 
TOP
 ABSTRACT
 INTRODUCTION
METHOD
 RESULTS
 DISCUSSION
 REFERENCES
 
Delirium is an organic psychiatric syndrome characterized by fluctuating consciousness and impairment in perception, cognition, and behavior.1,2 Common features include a disturbance in the sleep–wake cycle, affective lability, delusions and perceptual disturbances, and language and thought disorders.1,2 An excess of dopamine, glutamate, and norepinephrine, diminution of cholinergic function, and disturbances in gamma-aminobutyric acid and serotonergic activity have been implicated in its pathogenesis.2 Untreated, delirium is associated with significant morbidity and mortality. The conventional (first-generation) antipsychotics (e.g., haloperidol, chlorpromazine) have been the mainstay of treatment of agitation and psychosis associated with delirium;1 haloperidol has been considered by most clinicians to be the drug of first choice.1 Second-generation antipsychotic agents have been reported to have a lower incidence of extrapyramidal side effects and tardive dyskinesia in patients with schizophrenia and bipolar disorder,3 which has resulted in their increased use in the treatment of delirium patients, as well. However, there is still no consensus regarding standard pharmacologic treatment of this syndrome that takes use of second-generation antipsychotic agents into account. There are only a limited number of studies and case reports4–19 using second-generation antipsychotics (risperidone, quetiapine, olanzapine, and ziprasidone) in the treatment of delirium; to our knowledge, there are no published case reports or studies using aripiprazole.

Aripiprazole is approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia, bipolar mania, and bipolar maintenance therapy. Similar to other first- and second-generation antipsychotics, it is in clinical use for the treatment of behavioral disturbance and psychosis associated with dementia and delirium. Because experience with aripiprazole treatment in schizophrenia and bipolar disorder suggests a minimal side-effect burden, we hypothesized that it would be a useful agent in the treatment of delirium patients. Aripiprazole has little effect on the Q–Tc interval, prolactin levels, serum glucose and lipids, and weight.20–24 Aripiprazole is also generally less sedating than most of the other second-generation antipsychotics, and it has no appreciable affinity for cholinergic muscarinic receptors. The drug’s partial agonism at the dopamine D2 receptor may help improve attention, concentration, and sleep–wake cycle reversal in delirium and psychosis patients. Thus, aripiprazole may have a unique role in the treatment of hypoactive delirium.


  METHOD

 
TOP
 ABSTRACT
 INTRODUCTION
 METHOD
RESULTS
 DISCUSSION
 REFERENCES
 
Design and Subjects
We treated medically ill delirium patients (N=14) with aripiprazole between August 2004 and February 2005.

Patients (N=14) were between the ages of 18 and 85 and met DSM-IV-TR criteria for a diagnosis of delirium. Patients were selected from routine consultation requests made to our Consultation–Liaison Psychiatry Service by medical personnel. After patients were seen and a DSM-IV-TR diagnosis of delirium was established, use of a psychotropic medication was considered (Table 1). It should be noted that at the time of treatment of these patients, the FDA had not yet issued a warning regarding an increased incidence of cerebrovascular events in elderly dementia patients treated with aripiprazole or a warning regarding an increased risk of death in elderly patients with dementia treated for behavioral disorders with second-generation antipsychotic medications. A warning had been issued regarding an increased risk of stroke in such patients treated with risperidone and olanzapine.


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TABLE 1. Aripiprazole in the Treatment of Delirium: Pretreatment Data



Procedures
Psychiatric diagnoses were determined by the consultant psychiatrist, using DSM-IV-TR criteria for delirium.25 The Delirium Rating Scale–Revised-98 (DRS-R-98) and Clinical Global Impression (CGI) scale scores were also recorded by the same consulting psychiatrist. The DRS-R-98 is a useful method for quantifying treatment responses in delirium patients and is routinely used in clinical practice.26 According to Trzepacz et al., cut-off scores of 15–17 best discriminate delirium from non-delirium patients.26 The CGI is a scale widely used by clinicians to assess severity of illness and global improvement.27 CGI severity scores, rated 1–7, were recorded as 1: Normal, not at all ill, 2: Borderline mentally ill, 3: Mildly ill, 4: Moderately ill, 5: Markedly ill, 6: Severely ill, and 7: among the Most Extremely Ill patients. Global improvement scores (1–7) were recorded as 1: Very Much, 2: Much, 3: Minimally improved, 4: having No Change, or 5: being Minimally Worse, 6: Much Worse, or 7: Very Much Worse. DRS-R-98 and CGI scores were assessed on initial consultation, before treatment with aripiprazole, and serially throughout treatment.

Aripiprazole was used in a flexible dosing range, from 5 mg/day to 15 mg/day, titrated over a 7-day period, with dose increases on Day 3 and Day 7, as clinically indicated. The dose of aripiprazole was selected on the basis of our clinical experience and is comparable to the dose ranges of the other second-generation antipsychotics prescribed to patients with delirium (olanzapine: 2.5 mg–7.5 mg; risperidone: 0.5 mg–2 mg; and quetiapine: 50 mg–200 mg).4 Patients were followed as clinically indicated. All patients were treated by one clinician (DAS).

The medical history of each patient was reviewed with particular attention to cardiovascular and cerebrovascular disease, diabetes (or impaired fasting blood glucose), hypertension, obesity, dyslipidemia, and risk factors for the metabolic syndrome, given that the second-generation antipsychotics, as a class, have been implicated in exacerbating and potentially causing such problems.28–31 We recorded pre- and post-treatment measures of glucose, Q–Tc, blood pressure, and heart rate, and, when clinically applicable, lipids and body weight. Metabolic syndrome was defined, using the Adult Treatment Panel III criteria,32 by presence of more than three of the following: 1) high blood pressure, that is, ≥130/85 mmHg (or a history of hypertension); 2) abdominal obesity, that is, waist circumference >102 cm (40 inches) in men and >88 cm (35 inches) in women; 3) fasting blood glucose ≥110 mg/dl (or a history of diabetes mellitus); 4) fasting HDL cholesterol <40 mg/dl in men and <50 mg/dl in women; 5) fasting triglycerides ≥150 mg/dl. In some cases, waist circumference measurement was not available. In these instances, presence or absence of abdominal obesity was determined by visual inspection. Pretreatment electrocardiograms were obtained in all cases, in light of reports of Q–Tc prolongation and concern about ventricular arrhythmias with antipsychotics.33,34 Follow-up blood work (glucose, lipid profile) and electrocardiograms were performed as clinically indicated. Adverse effects, including extrapyramidal symptoms, were recorded. Results are presented as frequencies, percentages, or means (with standard deviations [SD]), as appropriate. Improvements in DRS-R-98 and CGI scores were computed with scale scores from the day of maximum improvement.


  RESULTS

 
TOP
 ABSTRACT
 INTRODUCTION
 METHOD
 RESULTS
DISCUSSION
 REFERENCES
 
We treated 14 patients with aripiprazole over a 7-month period. The mean (standard deviation [SD]) age of the patients was 70.9 (11.3) years. Six of the patients were men and eight were women (Table 2). The mean dose of aripiprazole used was 8.9 (3.5) mg. Only two patients received a dose higher than 10 mg. Maximum treatment response occurred at a mean of 6.2 (3.8) days. Four patients also received as-needed haloperidol in the first few days of treatment. Medical etiologies of delirium (Table 1) included medication (N=9), infection (N=6), and "other" (N=4). Five patients were status-postsurgery; two had preexisting dementia; one had a brain injury; two had HIV infection; and one had a brain tumor. Twelve of the 14 cases had multiple contributing etiologies for their delirium.


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TABLE 2.  Aripiprazole in the Treatment of Delirium: Results



DRS-R-98 scores declined from 25.1 (5.2) on initial evaluation to 9.4 (4.9) at treatment end-point. Fifty percent of the patients (7/14) had improved significantly by Day 5, as indicated by a ≥50% reduction in DRS-R-98 scores. Twelve of the 14 patients had a reduction in their DRS-R-98 scores ≥50% by treatment end-point.

Before treatment with aripiprazole, these patients were markedly impaired. Only three patients in the case series had initial CGI Severity scores less than 5 (moderately-to-mildly ill), and only three had DRS-R-98 scores <25. Eight of the 14 patients were in restraints, and 6 were on constant observation when treatment began. No patients needed these interventions after receiving treatment with aripiprazole. Mean CGI Severity scores at the beginning of treatment were 5.2 (1.1), with a mean Global Improvement score after treatment of 2.1 (1.0), indicating that patients treated with aripiprazole were Much Improved.

There were no cerebrovascular accidents during treatment and no cases of ventricular arrhythmias. One patient had a cardiac arrest and also went into atrial fibrillation shortly after aripiprazole was discontinued. Baseline electrocardiograms showed a mean (SD) Q–Tc interval of 44244 msec. Follow-up ECGs were obtained in 10 of the 14 patients, with mean (SD) Q–Tc interval decreasing from 45150 msec to 43422 msec on aripiprazole. Five patients (N=14) had an initial Q–Tc interval ≥450 msec. In these five patients, no further prolongation took place with aripiprazole treatment, and, in three cases, the Q–Tc interval fell below 450 msec during aripiprazole treatment. Q–Tc interval increased in three patients, including one patient with a Q–Tc interval increase to 486 msec. Aripiprazole was not discontinued in that case.

Pretreatment, nine patients met criteria for the metabolic syndrome. There were two patients on lipid-lowering agents for whom no pretreatment lipid data were available. They could not be assessed for the metabolic syndrome. No patients required insulin or oral hypoglycemic agents during aripiprazole treatment. Fasting blood glucose levels decreased from a mean (SD) of 176.1 (75.1) mg/dl to 116.2 (42.0) mg/dl. Blood glucose levels increased in two of the 14 patients (from 110 to 128 mg/dl and 79 to 91 mg/dl), but decreased in all other patients.

After discontinuation of aripiprazole, one patient experienced a cardiac arrest secondary to sepsis, and another patient experienced respiratory distress from aspiration pneumonia. Both patients died.


  DISCUSSION

 
TOP
 ABSTRACT
 INTRODUCTION
 METHOD
 RESULTS
 DISCUSSION
REFERENCES
 
In our case series, aripiprazole demonstrated apparent clinical efficacy in the treatment of delirium, with a low rate of adverse side effects. Given its good clinical record in psychiatric patients and its relatively benign side-effect profile compared with other medications in its class, aripiprazole deserves consideration as a first-line agent when treating delirium. The use of a pharmacologic agent such as aripiprazole may be especially valuable in the vulnerable delirium patient who already shows metabolic and cardiovascular morbidity.

Although treatment of delirium with antipsychotic agents is usually brief in duration (days to weeks), the clinical reality remains that many of these patients may remain on antipsychotic medications for months or longer.35 Behavioral and perceptual disturbances due to underlying chronic cerebral dysfunction, including irreversible dementias, may persist after successful management of the acute delirium and after hospital discharge.36–39 This occurs both in cases where the cause of the delirium is known and addressed medically and in cases where the cause of the delirium is never elucidated.36–39 Chronic antipsychotic medication use puts patients at an increased risk for cardiac events, hyperglycemia, hyperlipidemia, obesity, and the metabolic syndrome. These side effects potentially increase morbidity and mortality. The risk of tardive dyskinesia is increased in elderly patients who are prescribed first-generation antipsychotic medications.40 The advantages of a medication with a low rate of cardiac, extrapyramidal, and metabolic side effects are even more apparent with long-term use in a medically ill population.

The FDA recently issued a warning regarding an increased incidence of cerebrovascular events in elderly dementia patients treated with aripiprazole. This was based on three trials that were conducted in which aripiprazole was used to treat psychosis in patients with Alzheimer’s disease. There were 2/343 patients on placebo and 8/595 patients on aripiprazole who had "cardiovascular adverse events" during the study or within 30 days of termination of treatment. Although the pooled data did not reveal a statistically significant difference between aripiprazole and placebo, one of the three trials showed a significant difference for events on medication (p=0.03). A dose–response relationship was observed in this trial. Patients who had treatment-emergent events were reported to have cerebrovascular accidents, cerebral ischemia, intracerebral hemorrhage, or facial paralysis. Review articles on the association between second-generation antipsychotics and cerebrovascular events have drawn mixed conclusions.41–50 Also, the FDA has issued a warning with respect to the treatment of behavioral disorders in elderly patients with dementia, stating that the use of second-generation antipsychotics is associated with increased mortality.45 Examination of the specific causes of these deaths revealed that most were either due to heart-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia). Clearly, patients with delirium overlap with those who have dementia; however, only a subset of patients who have delirium also have an underlying dementia. Even though there is a potential risk in using these medications, the alternative of leaving the delirium untreated may pose a greater risk of morbidity and mortality. One patient in our case series had a cardiac arrest, and another had respiratory failure. Both patients died; neither was taking aripiprazole when the events took place. Clearly, all second-generation antipsychotics with FDA warnings should be used with caution.

Despite our positive findings, there are important limitations of this case series. These data are based on a small number of patients (N=14), and the treatment was not blinded or placebo-controlled. Also, four patients received haloperidol prn in the first few days of treatment.

In conclusion, in this case series, aripiprazole appeared to be a safe and effective treatment of delirium in medically ill patients. Larger, controlled studies are warranted to further explore these preliminary findings.


  ACKNOWLEDGMENTS

 
This work was presented in part at the Annual Meeting of the Academy of Psychosomatic Medicine, Albuquerque, NM, Nov 17–20, 2005.

David A. Straker, D.O., and Peter A. Shapiro, M.D., are on the Speaker’s Bureau of Pfizer. Philip R. Muskin, M.D., is on the Speaker’s Bureau of AstraZeneca, Bristol-Myers, Cephalon, Forest, GSK, Janssen, and Pfizer, and is a consultant for AstraZeneca, Bristol-Myers, Cephalon, Forest, GSK, Janssen, Orphan, and Pfizer, and has a grant from Bristol-Myers and Forest.


  REFERENCES

 
TOP
 ABSTRACT
 INTRODUCTION
 METHOD
 RESULTS
 DISCUSSION
 REFERENCES
 

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