Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

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.

Study Overview

• Status: Completed
• Conditions: Hyperactive Delirium
• Intervention / Treatment: Drug: Quatiapine; Drug: Haloperidol

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tamer Habib, MD; Phone Number: +201228425152; Email: tamer_zakhary@hotmail.com
• Study Contact Backup: Name: Islam Ahmed, PharmD; Phone Number: +201289849292; Email: islamelsayed@med.suez.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Medicine, Alexandria University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleeping hours	Sleeping hours per night	Day 3
Sleeping hours	Sleeping hours per night	Day 7
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
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

Collaborators and Investigators

• Sponsor: Alexandria University
• Collaborators: Suez Canal University; Gezira University
• Investigators: Principal Investigator: Tamer N. Habib, MD, University of Alexandria; Study Chair: Islam E. Ahmed, PharmD, Faculty of Medicine, Suez-canal University; Study Director: Ibrahim K. Luttfi, PHD, Faculty of Medicine, Gezira University

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2023
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: antipsychotics; Critical Care; Quetiapine; Haloperidol; Hyperactive Delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Hyperkinesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Anti-Dyskinesia Agents; Haloperidol; Haloperidol decanoate
• Other Study ID Numbers: QHMHD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No