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Completed

NCT Number: NCT05690698

Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine, Alexandria University Hospitals

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quatiapine

Drug

Atypical antipsychotic

Haloperidol

Drug

Antipsychotic

Primary outcomes

  1. Response rate

    Time frame: 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 outcomes

  1. In-hospital mortality

    Time frame: week 6 from enrollment

    In-hospital all cause mortality

  2. ICU-mortality

    Time frame: week 6 from enrollment

    ICU all cause mortality

  3. Need for MV

    Time frame: week 6 from enrollment

    Need for mechanical ventilation during ICU stay

  4. ICU stay

    Time frame: week 6 from enrollment

    Number of days of ICU stay

  5. Hospital stay

    Time frame: week 6 from enrollment

    Number of days of hospital stay

Other outcomes

  1. Sleeping hours

    Time frame: Day 3

    Sleeping hours per night

  2. Sleeping hours

    Time frame: Day 7

    Sleeping hours per night

  3. Delirium Rating Scale-revised-98 severity score

    Time frame: 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

  4. Delirium Rating Scale-revised-98 severity score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2023
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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