Efficacy of Quetiapine for Pediatric Delirium

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT02056171
First received: February 4, 2014
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Delirium
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 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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
Other Name: Seroquil
Placebo Comparator: Placebo
A randomized group will receive placebo, and not quetiapine.
Other: Placebo

  Eligibility

Ages Eligible for Study:   1 Year to 22 Years
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT02056171

Contacts
Contact: Chani Traube, MD 212-746-3056 chr9008@med.cornell.edu

Locations
United States, New York
NY Prebyterian Hospital/Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Principal Investigator: Chani Traube, MD         
Sub-Investigator: Gabrielle Silver, MD         
Sub-Investigator: Robert Witcher, PharmD         
Sub-Investigator: Elena Mendez-Rico, PharmD         
Sub-Investigator: Christine Joyce, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Chani Traube, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02056171     History of Changes
Other Study ID Numbers: 1309014323
Study First Received: February 4, 2014
Last Updated: March 6, 2014
Health Authority: United States: Data and Safety Monitoring Board

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

Additional relevant MeSH terms:
Delirium
Delirium, Dementia, Amnestic, Cognitive Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 30, 2014