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Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

Primary Purpose

Hyperactive Delirium

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Quatiapine
Haloperidol
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperactive Delirium focused on measuring Critical Care, Hyperactive Delirium, antipsychotics, Haloperidol, Quetiapine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of Medicine, Alexandria University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quatiapine group (n=50)

Haloperidol group (n=50)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

In-hospital mortality
In-hospital all cause mortality
ICU-mortality
ICU all cause mortality
Need for MV
Need for mechanical ventilation during ICU stay
ICU stay
Number of days of ICU stay
Hospital stay
Number of days of hospital stay

Full Information

First Posted
December 28, 2022
Last Updated
August 27, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05690698
Brief Title
Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium
Official Title
Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 9, 2023 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperactive Delirium
Keywords
Critical Care, Hyperactive Delirium, antipsychotics, Haloperidol, Quetiapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel random assignment to receive either oral quetiapine (25-50 mg/day) or haloperidol (1-2 mg/day)
Masking
ParticipantCare Provider
Masking Description
Double blinded trial
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quatiapine group (n=50)
Arm Type
Experimental
Arm Description
Quetiapine (25-50 mg/day) according to their symptoms of agitations.
Arm Title
Haloperidol group (n=50)
Arm Type
Active Comparator
Arm Description
Haloperidol (1-2 mg/day) according to their symptoms of agitations.
Intervention Type
Drug
Intervention Name(s)
Quatiapine
Intervention Description
Atypical antipsychotic
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Intervention Description
Antipsychotic
Primary Outcome Measure Information:
Title
Response rate
Description
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
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
In-hospital mortality
Description
In-hospital all cause mortality
Time Frame
week 6 from enrollment
Title
ICU-mortality
Description
ICU all cause mortality
Time Frame
week 6 from enrollment
Title
Need for MV
Description
Need for mechanical ventilation during ICU stay
Time Frame
week 6 from enrollment
Title
ICU stay
Description
Number of days of ICU stay
Time Frame
week 6 from enrollment
Title
Hospital stay
Description
Number of days of hospital stay
Time Frame
week 6 from enrollment
Other Pre-specified Outcome Measures:
Title
Sleeping hours
Description
Sleeping hours per night
Time Frame
Day 3
Title
Sleeping hours
Description
Sleeping hours per night
Time Frame
Day 7
Title
Delirium Rating Scale-revised-98 severity score
Description
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
Time Frame
Day 3
Title
Delirium Rating Scale-revised-98 severity score
Description
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
Time Frame
Day 7

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamer N. Habib, MD
Organizational Affiliation
University of Alexandria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Islam E. Ahmed, PharmD
Organizational Affiliation
Faculty of Medicine, Suez-canal University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ibrahim K. Luttfi, PHD
Organizational Affiliation
Faculty of Medicine, Gezira University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Alexandria University Hospitals
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

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