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Efficacy of Quetiapine for Pediatric Delirium

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Weill Medical College of Cornell University Identifier:
First received: February 4, 2014
Last updated: October 31, 2016
Last verified: October 2016
This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.

Condition Intervention Phase
Drug: quetiapine
Other: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Quetiapine for Pediatric Delirium

Resource links provided by NLM:

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Time to first resolution of delirium [ Time Frame: Within the first 10 days after study enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total ICU days with delirium [ Time Frame: Within 30 days after study enrollment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in delirium severity [ Time Frame: within 10 days of study enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   1 Year to 22 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Sponsors and Collaborators
Weill Medical College of Cornell University
Principal Investigator: Chani Traube, MD Weill Medical College of Cornell University
  More Information

Responsible Party: Weill Medical College of Cornell University Identifier: NCT02056171     History of Changes
Other Study ID Numbers: 1309014323 
Study First Received: February 4, 2014
Last Updated: October 31, 2016
Health Authority: United States: Data and Safety Monitoring Board
Individual Participant Data  
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
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 processed this record on December 02, 2016