---
title: Efficacy of Quetiapine for Pediatric Delirium
nct_id: NCT02056171
overall_status: TERMINATED
phase: PHASE1, PHASE2
sponsor: Weill Medical College of Cornell University
study_type: INTERVENTIONAL
primary_condition: Delirium
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02056171.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02056171"
ct_last_update_post_date: 2017-12-13
last_seen_at: "2026-05-12T06:34:06.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy of Quetiapine for Pediatric Delirium

**NCT ID:** [NCT02056171](https://clinicaltrials.gov/study/NCT02056171)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Unable to recruit subjects at our site within the past year.
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 6
- **Lead Sponsor:** Weill Medical College of Cornell University
- **Conditions:** Delirium
- **Start Date:** 2015-03
- **Completion Date:** 2016-12
- **CT.gov Last Update:** 2017-12-13

## Brief Summary

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

## 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.

## Eligibility

- **Minimum age:** 1 Year
- **Maximum age:** 22 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Quetiapine** (EXPERIMENTAL) — A randomized group will receive quetiapine as treatment for delirium.
- **Placebo** (PLACEBO_COMPARATOR) — A randomized group will receive placebo, and not quetiapine.

## Interventions

- **quetiapine** (DRUG) — Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.
- **Placebo** (OTHER) — Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.

## Primary Outcomes

- **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 Outcomes

- **Total ICU Days With Delirium** _(time frame: Within 10 days after study enrollment)_

## 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

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.columbia university medical center|new york|new york|united states` — added _(2026-05-12)_
- `locations.ny prebyterian hospital/weill cornell medical center|new york|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02056171.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02056171*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*