Efficacy of Quetiapine for Pediatric Delirium

Phase 2TerminatedNCT02056171

Weill Medical College of Cornell University6 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Delirium

Interventions

quetiapineDRUG

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

PlaceboOTHER

Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.

Eligibility

Sex: ALLMin age: 1 YearMax age: 22 Years

Medical Language ↔ Plain English

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

Locations (2)

Columbia University Medical Center

New York, New York, United States

NY Prebyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Within the first 10 days after study enrollment

Secondary Outcomes

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.

Time frame: Within 10 days after study enrollment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.