Efficacy of Quetiapine for Pediatric Delirium

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

Study Overview

• Status: Terminated
• Conditions: Delirium
• Intervention / Treatment: Drug: quetiapine; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • NY Prebyterian Hospital/Weill Cornell Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Resolution of Delirium	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.	Within the first 10 days after study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total ICU Days With Delirium	Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period.	Within 10 days after study enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Delirium Severity	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.	Baseline and 3 days of study drug initiation

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Chani Traube, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 4, 2014
• First Posted (Estimate): February 5, 2014

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: pediatrics; critical care; delirium; quetiapine
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: 1309014323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No