Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

Alexandria University

Status and phase: Completed; Phase 3

Conditions: Hyperactive Delirium

Treatments: Drug: Quatiapine; Drug: Haloperidol

Study type: Interventional

Funder types: Other

Identifiers

NCT05690698

QHMHD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Quatiapine group (n=50)

Experimental group

Description:

Quetiapine (25-50 mg/day) according to their symptoms of agitations.

Treatment:

Drug: Quatiapine

Haloperidol group (n=50)

Active Comparator group

Description:

Haloperidol (1-2 mg/day) according to their symptoms of agitations.

Treatment:

Drug: Haloperidol