Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

NCT ID: NCT05690698

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-09
• Study Completion Date: 2023-07-15

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.

Conditions

Hyperactive Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Quatiapine group (n=50)

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

Group Type: EXPERIMENTAL

Quatiapine

Intervention Type: DRUG

Atypical antipsychotic

Haloperidol group (n=50)

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

Group Type: ACTIVE_COMPARATOR

Haloperidol

Intervention Type: DRUG

Antipsychotic

Interventions

Quatiapine

Atypical antipsychotic

Intervention Type: DRUG

Haloperidol

Antipsychotic

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamer N. Habib, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Islam E. Ahmed, PharmD

Role: STUDY_CHAIR

Faculty of Medicine, Suez-canal University

Ibrahim K. Luttfi, PHD

Role: STUDY_DIRECTOR

Faculty of Medicine, Gezira University

Locations

Faculty of Medicine, Alexandria University Hospitals

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

QHMHD

Identifier Type: -

Identifier Source: org_study_id