Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

Phase 3

Completed

• Conditions: Hyperactive Delirium
• Interventions: Drug: Quatiapine; Drug: Haloperidol

• Registration Number: NCT05690698
• Lead Sponsor: Alexandria University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-12-28
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-19
• Status Verified: 2023-03
• Study Start: 2023-04-09
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-15
• Last Update Submitted: 2023-08-27
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quatiapine group (n=50)	Quatiapine	Quetiapine (25-50 mg/day) according to their symptoms of agitations.
Haloperidol group (n=50)	Haloperidol	Haloperidol (1-2 mg/day) according to their symptoms of agitations.

Primary Outcome Measures

Name	Time	Method
Response rate	Day 7	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

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	week 6 from enrollment	In-hospital all cause mortality
ICU-mortality	week 6 from enrollment	ICU all cause mortality
Need for MV	week 6 from enrollment	Need for mechanical ventilation during ICU stay
ICU stay	week 6 from enrollment	Number of days of ICU stay
Hospital stay	week 6 from enrollment	Number of days of hospital stay

Trial Locations

Locations (1)

Faculty of Medicine, Alexandria University Hospitals; 🇪🇬 Alexandria, Egypt