Efficacy of Quetiapine for Pediatric Delirium
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|ClinicalTrials.gov Identifier: NCT02056171|
Recruitment Status : Terminated (Unable to recruit subjects at our site within the past year.)
First Posted : February 5, 2014
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Delirium||Drug: quetiapine Other: Placebo||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Quetiapine for Pediatric Delirium|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
A randomized group will receive quetiapine as treatment for delirium.
Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.
Other Name: Seroquil
Placebo Comparator: Placebo
A randomized group will receive placebo, and not quetiapine.
Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
- 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.
- Total ICU Days With Delirium [ Time Frame: Within 10 days after study enrollment ]Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period.
- Change in Delirium Severity [ Time Frame: Baseline and 3 days of study drug initiation ]Participants were screened for delirium daily using the Cornell Assessment for Pediatric Delirium, which assigns a delirium score between 0 (no delirium) to 32 (severe delirium). This describes the change in delirium score between study drug initiation (either quetiapine or placebo) and 72 hours. A decrease in score implies an improvement in delirium severity. For the quetiapine group, there was a median decrease in scale score (for the 3 subjects) of 1; for the placebo group, there was no change in delirium screen scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056171
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|NY Prebyterian Hospital/Weill Cornell Medical Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Chani Traube, MD||Weill Medical College of Cornell University|