Hyperactive DeliriumPhase 3NCT05690698
Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium
A Phase 3 study testing Quatiapine and Haloperidol in people with Hyperactive Delirium, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperactive Delirium
- What is being tested?
- Quatiapine and Haloperidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Apr 2023to 15 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Quatiapine, Haloperidol
- Keywords
- Critical Care, Hyperactive Delirium, antipsychotics, Haloperidol, Quetiapine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuatiapineDrug
Atypical antipsychotic
HaloperidolDrug
Antipsychotic
| Study group | Role | What they receive |
|---|---|---|
| Quatiapine group (n=50) | Experimental | Quetiapine (25-50 mg/day) according to their symptoms of agitations. Receives: Drug: Quatiapine |
| Haloperidol group (n=50) | Active comparator | Haloperidol (1-2 mg/day) according to their symptoms of agitations. Receives: Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 7
Secondary outcomes (5)
In-hospital mortality
In-hospital all cause mortality
Measured: week 6 from enrollment
ICU-mortality
ICU all cause mortality
Measured: week 6 from enrollment
Need for MV
Need for mechanical ventilation during ICU stay
Measured: week 6 from enrollment
ICU stay
Number of days of ICU stay
Measured: week 6 from enrollment
Hospital stay
Number of days of hospital stay
Measured: week 6 from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start9 Apr 2023
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperactive DeliriumStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel random assignment to receive either oral quetiapine (25-50 mg/day) or haloperidol (1-2 mg/day)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamer N. Habib, MD, Principal investigator, University of AlexandriaIslam E. Ahmed, PharmD, Study chair, Faculty of Medicine, Suez-canal UniversityIbrahim K. Luttfi, PHD, Study director, Faculty of Medicine, Gezira University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690698
- Sponsor's protocol ID
- QHMHD
- Status last verified
- Mar 2023
- First submitted
- 28 Dec 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium
- ClinicalTrials.gov ID
- NCT05690698
- Acronym / sponsor ID
- QHMHD
- Conditions
- Hyperactive Delirium
- Keywords
- Critical Care, Hyperactive Delirium, antipsychotics, Haloperidol, Quetiapine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 9 Apr 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parallel random assignment to receive either oral quetiapine (25-50 mg/day) or haloperidol (1-2 mg/day)
| Arm | Type | Receives |
|---|---|---|
| Quatiapine group (n=50) | Experimental | Drug: QuatiapineQuetiapine (25-50 mg/day) according to their symptoms of agitations. |
| Haloperidol group (n=50) | Active comparator | Drug: HaloperidolHaloperidol (1-2 mg/day) according to their symptoms of agitations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (7 listed)
- Suspected substance-induced delirium
- Previous use of antipsychotics
- Known allergy or intolerance to the study drugs
- Pregnancy or breast feeding
- Acute renal injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuatiapineAtypical antipsychotic | Drug | Quatiapine group (n=50) |
| HaloperidolAntipsychotic | Drug | Haloperidol group (n=50) |
Primary outcome
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
5 secondary outcomes
In-hospital mortality
Time frame: week 6 from enrollment
ICU-mortality
Time frame: week 6 from enrollment
Need for MV
Time frame: week 6 from enrollment
ICU stay
Time frame: week 6 from enrollment
Hospital stay
Time frame: week 6 from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Hyperactive Delirium
Not yet recruitingPhase 4
Safety and Efficacy of Esketamine - Dexmedetomidine Combination Versus Dexmedetomidine Monotherapy for Hyperactive Delirium in ICU Patients on Non-Invasive Respiratory Support (SEED-NIRS Trial): Study Protocol of a Randomized Controlled Trial
Dexmedetomidine, Ketamine
Active, not recruitingObservational study
Intelligent Intensive Care Unit
Delirium, Confusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamer N. Habib, MD principal investigator
University of Alexandria
Islam E. Ahmed, PharmD study chair
Faculty of Medicine, Suez-canal University
Ibrahim K. Luttfi, PHD study director
Faculty of Medicine, Gezira University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quatiapine and Haloperidol in people with Hyperactive Delirium, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.