DeliriumPhase 3NCT02297763
Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients
A Phase 3 study testing quetiapine in people with Delirium, run by Seoul National University Hospital.
Trial summary
The purpose of this study is to evaluate the efficacy of low dose quetiapine for the prophylaxis of delirium in critically ill patients in medical intensive care unit. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Delirium
- What is being tested?
- quetiapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Sep 2016
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 19 years of age, admitting to medical ICU, anticipated to stay more than 72hours
Who cannot join
- Female patients who are pregnant or breastfeeding
- active delirium
- Received other anti-psychotic drug before attend the study
- severe bradycardia
- alcohol intoxication
- No written consent from the legal representatives
- Being ill with renal or hepatic failure
About this study
The purpose of this study is to evaluate the efficacy of low dose quetiapine for the prophylaxis of delirium in critically ill patients in medical intensive care unit.
- Conditions
- Delirium
- Being tested
- quetiapine, placebo
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapineDrug
patient body weight <50kg : quetiapine 12.5mg patient body weight >=50kg : quetiapine 25mg
quetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form.
The study medicine(quetiapine) was provided as liquid form (medicine was pulverized and melted in 10cc water).
placeboDrug
The placebo is made of 100mg of corn starch which is melted in 10cc water.
| Study group | Role | What they receive |
|---|---|---|
| quetiapine | Active comparator | quetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form. Receives: Drug: quetiapine |
| placebo | Placebo comparator | The placebo is made of 100mg of corn starch which is melted in 10cc water. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of delirium within 14 days after admitting to ICU (Rate)
Measured: 14 days after admitting to intensive care unit
Secondary outcomes (4)
Duration of delirium occurring within 14 days after admitting to ICU (Days)
Measured: 14 days after admitting to ICU
Length of stay in ICU and hospital (Days)
Measured: up to 24 weeks
60 days in hospital mortality (Rate)
Measured: 60 days after admitting to ICU
Duration of mechanical ventilation in ICU (Days)
Measured: 14days after admitting to intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionSep 2016 (estimated)
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 Seoul National University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297763
- Sponsor's protocol ID
- YJLSM2014
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02297763
- Acronym / sponsor ID
- YJLSM2014
- Conditions
- Delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (estimated)
- First posted
- 21 Nov 2014 (estimated)
- 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 purpose of this study is to evaluate the efficacy of low dose quetiapine for the prophylaxis of delirium in critically ill patients in medical intensive care unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quetiapine | Active comparator | Drug: quetiapinequetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form. |
| placebo | Placebo comparator | Drug: placeboThe placebo is made of 100mg of corn starch which is melted in 10cc water. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Greater than or equal to 19 years of age, admitting to medical ICU, anticipated to stay more than 72hours
Key exclusion criteria (7 listed)
- Female patients who are pregnant or breastfeeding
- active delirium
- Received other anti-psychotic drug before attend the study
- severe bradycardia
- alcohol intoxication
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 |
|---|---|---|
| quetiapinepatient body weight <50kg : quetiapine 12.5mg patient body weight >=50kg : quetiapine 25mg quetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form. The study medicine(quetiapine) was provided as liquid form (medicine was pulverized and melted in 10cc water). | Drug | quetiapine |
| placeboThe placebo is made of 100mg of corn starch which is melted in 10cc water. | Drug | placebo |
Primary outcome
Development of delirium within 14 days after admitting to ICU (Rate)
Time frame: 14 days after admitting to intensive care unit
4 secondary outcomes
Duration of delirium occurring within 14 days after admitting to ICU (Days)
Time frame: 14 days after admitting to ICU
Length of stay in ICU and hospital (Days)
Time frame: up to 24 weeks
60 days in hospital mortality (Rate)
Time frame: 60 days after admitting to ICU
Duration of mechanical ventilation in ICU (Days)
Time frame: 14days after admitting to intensive care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing quetiapine in people with Delirium, run by Seoul National University Hospital.
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: status not confirmed, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Development of delirium within 14 days after admitting to ICU (Rate) (time frame: 14 days after admitting to intensive care unit). 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 21 Nov 2014.