DeliriumPhase 2NCT05793632
Quetiapine in Prevention of Delirium
A Phase 2 study testing Quetiapine in people with Delirium, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim is to study the effectiveness of Quetiapine in preventing delirium in the elderly patients with multiple risks for delirium. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 15 Apr 2023
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with anemia
- Sedated patients
- Hypotensive patients
- Immobilized patients
- Patients with visual or auditory impairment
Who cannot join
- Patients or guardians refuse to participate
- Patients diagnosed with delirium
- Contraindication for delirium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Quetiapine in the Prevention of ICU Delirium in Elderly Patients at a High Risk
The aim is to study the effectiveness of Quetiapine in preventing delirium in the elderly patients with multiple risks for delirium.
- Conditions
- Delirium
- Being tested
- Quetiapine
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
The patients will be randomly divided into two equal groups group Q and group C. Randomization will be done by computer-generated number lists and using opaque sealed envelopes.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine | Experimental | The patients with multiple risks for delirium will receive 25 mg/day PO Receives: Drug: Quetiapine |
| Non pharmacological preventive bundle | No intervention | The patients will only be monitored with application of delirium preventive bundle without pharmacological agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quetiapine in preventing delirium
The presence of delirium will be monitored among the patients in the two groups using ICU-Confusion Assessment Method 7 score for delirium where a score of (0-2 = no delirium, 3-5 = mild to moderate delirium and a score >5 = severe delirium)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walid Kamel, Principal investigator, Faculty of medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793632
- Sponsor's protocol ID
- Quetiapine
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Quetiapine in the Prevention of ICU Delirium in Elderly Patients at a High Risk
- ClinicalTrials.gov ID
- NCT05793632
- Acronym / sponsor ID
- Quetiapine
- Conditions
- Delirium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 31 Mar 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.
The aim is to study the effectiveness of Quetiapine in preventing delirium in the elderly patients with multiple risks for delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Experimental | Drug: QuetiapineThe patients with multiple risks for delirium will receive 25 mg/day PO |
| Non pharmacological preventive bundle | No intervention | –The patients will only be monitored with application of delirium preventive bundle without pharmacological agent |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with anemia
- Sedated patients
- Hypotensive patients
- Immobilized patients
- Patients with visual or auditory impairment
Key exclusion criteria (3 listed)
- Patients or guardians refuse to participate
- Patients diagnosed with delirium
- Contraindication for delirium
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 |
|---|---|---|
| QuetiapineThe patients will be randomly divided into two equal groups group Q and group C. Randomization will be done by computer-generated number lists and using opaque sealed envelopes. | Drug | Quetiapine |
Primary outcome
Quetiapine in preventing delirium
Time frame: 2 months
The presence of delirium will be monitored among the patients in the two groups using ICU-Confusion Assessment Method 7 score for delirium where a score of (0-2 = no delirium, 3-5 = mild to moderate delirium and a score >5 = severe delirium)
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 10 Jul 2023.
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The Danish Out-of-Hospital Cardiac Arrest Study
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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.
Walid Kamel principal investigator
Faculty of medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quetiapine in people with Delirium, run by Ain Shams 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 5 inclusion and 3 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 10 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Quetiapine in preventing delirium (time frame: 2 months). 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 10 Jul 2023.