Efficacy of Quetiapine for Pediatric Delirium

• ClinicalTrials.gov Identifier: NCT02056171
• Recruitment Status: Terminated
• First Posted: February 5, 2014
• Results First Posted: December 13, 2017
• Last Update Posted: December 13, 2017
• Sponsor: Weill Medical College of Cornell University
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Study Description

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT02056171
• Other Study ID Numbers: 1309014323
• First Posted: February 5, 2014
• 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; Neurocognitive Disorders; Mental Disorders; Quetiapine Fumarate; Antidepressive Agents; Psychotropic Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs