Efficacy of Quetiapine for Pediatric Delirium



Status:Terminated
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:1 - 22
Updated:12/15/2017
Start Date:March 2015
End Date:December 2016

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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.

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
We found this trial at
2
sites
New York, New York 10065
Principal Investigator: Chani Traube, MD
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Katherine Biagas, MD
Phone: 212-305-3552
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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