DeliriumPhase 1/2NCT02056171
Efficacy of Quetiapine for Pediatric Delirium
A Phase 1/2 study testing quetiapine in people with Delirium, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium. Read more about this study
- Who is it for?
- Ages 1 year to 22 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
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2015to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any patient in the PICU aged 1 year to 21 years old who is diagnosed with delirium
Who cannot join
- Age <1
- Richmond Agitation Sedation Scale (RASS) score of -4 or -5 (deeply sedated or unarousable).
- current treatment for alcohol withdrawal
- hepatic encephalopathy
- pregnancy
- diagnosis of major depressive disorder or bipolar disorder
Show all 10Show fewer
- diagnosis of movement disorder
- diagnosis of diabetic ketoacidosis
- baseline QTc >500 milliseconds
- non-English speaking subjects and/or parent/guardian
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Medical Center
New York, New York, 10032
NY Prebyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065
About this study
This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.
Read the detailed description
Many children in the ICU become confused, due to their underlying illness or treatment effects. The medical term for this confusion is delirium. In adults, a medication called quetiapine has been effective in treating delirium. This is considered an "off label" use as the FDA has not approved quetiapine for this indication.
Pediatricians have been using quetiapine to treat delirium in children as well, but there is currently no data proving that it is effective in children. This study is being done to determine if quetiapine is effective for the treatment of ICU delirium in children.
- Conditions
- Delirium
- Being tested
- quetiapine, Placebo
- Keywords
- delirium, pediatrics, critical care, 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
Also called Seroquil
Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.
PlaceboOther
Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine | Experimental | A randomized group will receive quetiapine as treatment for delirium. Receives: Drug: quetiapine |
| Placebo | Placebo comparator | A randomized group will receive placebo, and not quetiapine. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Resolution of Delirium
Participants were screened for delirium daily. This describes the number of days from study drug initiation (either quetiapine or placebo) to first resolution of delirium (defined as a score of less than 9 on teh Cornell Assessment of Pediatric Delirium [CAPD]). If delirium did not resolve within the 10 day period, this defaults to 10 days.
Measured: Within the first 10 days after study enrollment
Secondary outcomes (1)
Total ICU Days With Delirium
Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period.
Measured: Within 10 days after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Unable to recruit subjects at our site within the past year.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chani Traube, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056171
- Sponsor's protocol ID
- 1309014323
- Status last verified
- Dec 2017
- First submitted
- 4 Feb 2014
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Quetiapine for Pediatric Delirium
- ClinicalTrials.gov ID
- NCT02056171
- Acronym / sponsor ID
- 1309014323
- Conditions
- Delirium
- Keywords
- delirium, pediatrics, critical care, quetiapine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit subjects at our site within the past year.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.
Detailed description
Many children in the ICU become confused, due to their underlying illness or treatment effects. The medical term for this confusion is delirium. In adults, a medication called quetiapine has been effective in treating delirium. This is considered an "off label" use as the FDA has not approved quetiapine for this indication.
Pediatricians have been using quetiapine to treat delirium in children as well, but there is currently no data proving that it is effective in children. This study is being done to determine if quetiapine is effective for the treatment of ICU delirium in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Experimental | Drug: quetiapineA randomized group will receive quetiapine as treatment for delirium. |
| Placebo | Placebo comparator | Other: PlaceboA randomized group will receive placebo, and not quetiapine. |
Who may qualify
- Ages
- 1 year to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Any patient in the PICU aged 1 year to 21 years old who is diagnosed with delirium
Key exclusion criteria (10 listed)
- Age <1
- Richmond Agitation Sedation Scale (RASS) score of -4 or -5 (deeply sedated or unarousable).
- current treatment for alcohol withdrawal
- hepatic encephalopathy
- pregnancy
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 |
|---|---|---|
| quetiapineAlso: SeroquilPatients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine. | Drug | Quetiapine |
| PlaceboPatients who are diagnosed with delirium and assigned to the placebo arm will receive placebo. | Other | Placebo |
Primary outcome
Time to First Resolution of Delirium
Time frame: Within the first 10 days after study enrollment
Participants were screened for delirium daily. This describes the number of days from study drug initiation (either quetiapine or placebo) to first resolution of delirium (defined as a score of less than 9 on teh Cornell Assessment of Pediatric Delirium [CAPD]). If delirium did not resolve within the 10 day period, this defaults to 10 days.
1 secondary outcome
Total ICU Days With Delirium
Time frame: Within 10 days after study enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Delirium
RecruitingObservational study
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
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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.
Chani Traube, MD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing quetiapine in people with Delirium, run by Weill Medical College of Cornell University at 2 sites in United States.
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 10 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: stopped early, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to First Resolution of Delirium (time frame: Within the first 10 days after study enrollment). 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 13 Dec 2017.