Efficacy of Quetiapine for Pediatric Delirium

Delirium Clinical Trial

Official title:

Efficacy of Quetiapine for Pediatric Delirium

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02056171
• Other study ID #: 1309014323
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 4, 2014
• Last updated: December 12, 2017
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• quetiapine
Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.

Other:
• Placebo
Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York
United States	NY Prebyterian Hospital/Weill Cornell Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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