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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
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.

Condition or disease Intervention/treatment Phase
Delirium Drug: quetiapine Other: Placebo Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Quetiapine
A randomized group will receive quetiapine as treatment for delirium.
Drug: quetiapine
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.
Other: Placebo
Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   1 Year to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Any patient in the PICU aged 1 year to 21 years old who is diagnosed with delirium

Exclusion Criteria:

  • 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
  • diagnosis of movement disorder
  • diagnosis of diabetic ketoacidosis
  • baseline QTc >500 milliseconds
  • non-English speaking subjects and/or parent/guardian

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Chani Traube, MD Weill Medical College of Cornell University

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02056171     History of Changes
Other Study ID Numbers: 1309014323
First Posted: February 5, 2014    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Weill Medical College of Cornell University:
delirium
pediatrics
critical care
quetiapine

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs