Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

NCT05690698 | Completed Phase 3

• 1 other identifier: QHMHD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperactive Delirium

Keywords

Critical Care; Hyperactive Delirium; antipsychotics; Haloperidol; Quetiapine

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• In-hospital mortality

  week 6 from enrollment

• ICU-mortality

  week 6 from enrollment

• Need for MV

  week 6 from enrollment

• ICU stay

  week 6 from enrollment

• Hospital stay

  week 6 from enrollment

Other Outcomes (4)

• Sleeping hours

  Day 3

• Sleeping hours

  Day 7

• Delirium Rating Scale-revised-98 severity score

  Day 3

Study Arms (2)

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

Quatiapine DRUG

Atypical antipsychotic

Quatiapine group (n=50)

Haloperidol DRUG

Antipsychotic

Haloperidol group (n=50)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Alexandria University Hospitals

Alexandria, Egypt

Location

MeSH Terms

Interventions

Haloperidol

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blinded trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 19, 2023
• Study Start: April 9, 2023
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)