Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

Study Overview
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Brief Summary
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In population of intensive care unit (ICU), most studies compared atypical antipsychotics such as quetiapine with the traditional haloperidol in delirious patients of various forms and etiologies. The role of such agents in patients with hyperactive is not fully understood. This study compares the effectiveness of quetiapine with haloperidol in treating the hyperactive form of delirium in terms of their effects on morbidity, length of stay in the intensive care unit, and mortality in critically ill patients.

Detailed Description
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A common complication in the intensive care unit (ICU) that has recently been identified is delirium. Defining delirium as a sudden deterioration in attention, awareness, and cognition, which is not explained by any pre-existing neurocognitive disorder, but because of another medical condition, the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) clarified the definition of delirium. A dibenzothiazepine derivative with a novel and distinctive pharmacologic profile is quetiapine. The limbic system is overactive in delirium, which is one of its pathophysiologies. By obstructing the mesolimbic dopamine D2 receptors specifically, quetiapine may be able to regulate this hyperactivity. The objective of this study is to compare the effectiveness of quetiapine with haloperidol in treating the hyperactive form of delirium in terms of their effects on morbidity, length of stay in ICU, and mortality in critically ill patients. This research will not receive any grants, funding, or financial aid (NOT FUNDED STUDY). Collaborators declare that they have no conflicts of interest.

Official Title
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Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

Conditions
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Hyperactive Delirium

Intervention / Treatment
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* Drug: Quatiapine
* Drug: Haloperidol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who are diagnosed with hyperactive form of delirium during their ICU stay using CAM-ICU tool (the confusion assessment method for the intensive care unit) Exclusion Criteria: Suspected substance-induced delirium Previous use of antipsychotics Known allergy or intolerance to the study drugs Pregnancy or breast feeding Acute renal injury Hepatic failure Inability to tolerate oral drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel random assignment to receive either oral quetiapine (25-50 mg/day) or haloperidol (1-2 mg/day)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quatiapine group (n=50)<br>Quetiapine (25-50 mg/day) according to their symptoms of agitations. | Drug: Quatiapine<br>* Atypical antipsychotic<br>|
| Active Comparator: Haloperidol group (n=50)<br>Haloperidol (1-2 mg/day) according to their symptoms of agitations. | Drug: Haloperidol<br>* Antipsychotic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response rate is defined as a reduction of the DRS-R-98 severity score from its baseline for 50% or more and a DRS-R-98 severity score of 12 or less without relapse | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | In-hospital all cause mortality | week 6 from enrollment | 
| ICU-mortality | ICU all cause mortality | week 6 from enrollment | 
| Need for MV | Need for mechanical ventilation during ICU stay | week 6 from enrollment | 
| ICU stay | Number of days of ICU stay | week 6 from enrollment | 
| Hospital stay | Number of days of hospital stay | week 6 from enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical Care, Hyperactive Delirium, antipsychotics, Haloperidol, Quetiapine