Quetiapine Versus Haloperidol in the Management of Hypera... | NCT05690698

Studies
Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

NCT05690698

Sponsor

Alexandria University

Status

Completed

Last Update Posted

Aug 30, 2023Actual

Enrollment

100Actual

Phase

Phase 3

Conditions

Hyperactive Delirium

Interventions

Quatiapine
Haloperidol

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 9, 2023Actual

Primary Completion Date

Jul 15, 2023Actual

Completion Date

Jul 15, 2023Actual

First Submitted Date

Dec 28, 2022

First Submission Date that Met QC Criteria

Jan 17, 2023

First Posted Date

Jan 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2023

Last Update Posted Date

Aug 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Quatiapine group (n=50)	Experimental	Quetiapine (25-50 mg/day) according to their symptoms of agitations.	Drug: Quatiapine
Haloperidol group (n=50)	Active Comparator	Haloperidol (1-2 mg/day) according to their symptoms of agitations.	Drug: Haloperidol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quatiapine	Drug	Atypical antipsychotic	Quatiapine group (n=50)
Haloperidol

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tamer N. Habib, MD	University of Alexandria	Principal Investigator
Islam E. Ahmed, PharmD	Faculty of Medicine, Suez-canal University	Study Chair
Ibrahim K. Luttfi, PHD	Faculty of Medicine, Gezira University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Alexandria University Hospitals		Alexandria			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006220	Haloperidol

Ancestor Terms

ID	Term
D002090	Butyrophenones
D007659	Ketones
D009930	Organic Chemicals

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Browse Branches

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