Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

Hyperactive Delirium Clinical Trial

Official title:

Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05690698
• Other study ID #: QHMHD
• Status: Completed
• Phase: Phase 3
• Start date: April 9, 2023
• Est. completion date: July 15, 2023

Study information

• Verified date: March 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Hyperactive Delirium
• Hyperkinesis
• Psychomotor Agitation

Intervention

Drug:
• Quatiapine
Atypical antipsychotic
• Haloperidol
Antipsychotic

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Alexandria University Hospitals	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleeping hours	Sleeping hours per night	Day 3
Other	Sleeping hours	Sleeping hours per night	Day 7
Other	Delirium Rating Scale-revised-98 severity score	The DRS-R-98 is a valid measure of delirium severity over a broad range of symptoms and is a useful diagnostic and assessment tool, maximum severity score of 39 points	Day 3
Other	Delirium Rating Scale-revised-98 severity score	The DRS-R-98 is a valid measure of delirium severity over a broad range of symptoms and is a useful diagnostic and assessment tool, maximum severity score of 39 points	Day 7
Primary	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	In-hospital mortality	In-hospital all cause mortality	week 6 from enrollment
Secondary	ICU-mortality	ICU all cause mortality	week 6 from enrollment
Secondary	Need for MV	Need for mechanical ventilation during ICU stay	week 6 from enrollment
Secondary	ICU stay	Number of days of ICU stay	week 6 from enrollment
Secondary	Hospital stay	Number of days of hospital stay	week 6 from enrollment