Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05690698

Collaborator

Suez Canal University (Other), Gezira University (Other)

100

Enrollment

Location

Arms

5.5

Anticipated Duration (Months)

18.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperactive Delirium	Drug: Quatiapine Drug: Haloperidol	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel random assignment to receive either oral quetiapine (25-50 mg/day) or haloperidol (1-2 mg/day)Parallel random assignment to receive either oral quetiapine (25-50 mg/day) or haloperidol (1-2 mg/day)

Masking:

Double (Participant, Care Provider)

Masking Description:

Double blinded trial

Primary Purpose:

Treatment

Official Title:

Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium; Randomized-Controlled Trial

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jan 15, 2023

Anticipated Study Completion Date :

Jan 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Sleeping hours [Day 3]
Sleeping hours per night
Sleeping hours [Day 7]
Sleeping hours per night
Delirium Rating Scale-revised-98 severity score [Day 3]
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
Delirium Rating Scale-revised-98 severity score [Day 7]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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)