Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
6 participants
INTERVENTIONAL
2015-03-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Quetiapine
A randomized group will receive quetiapine as treatment for delirium.
quetiapine
Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.
Placebo
A randomized group will receive placebo, and not quetiapine.
Placebo
Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
quetiapine
Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.
Placebo
Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
* diagnosis of movement disorder
* diagnosis of diabetic ketoacidosis
* baseline QTc \>500 milliseconds
* non-English speaking subjects and/or parent/guardian
1 Year
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Weill Medical College of Cornell University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chani Traube, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Columbia University Medical Center
New York, New York, United States
NY Prebyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1309014323
Identifier Type: -
Identifier Source: org_study_id