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Efficacy of Quetiapine for Pediatric Delirium

Primary Purpose

Delirium

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
quetiapine
Placebo
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring delirium, pediatrics, critical care, quetiapine

Eligibility Criteria

1 Year - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Medical Center
  • NY Prebyterian Hospital/Weill Cornell Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Quetiapine

Placebo

Arm Description

A randomized group will receive quetiapine as treatment for delirium.

A randomized group will receive placebo, and not quetiapine.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 4, 2014
Last Updated
December 12, 2017
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT02056171
Brief Title
Efficacy of Quetiapine for Pediatric Delirium
Official Title
Efficacy of Quetiapine for Pediatric Delirium
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit subjects at our site within the past year.
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
delirium, pediatrics, critical care, quetiapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine
Arm Type
Experimental
Arm Description
A randomized group will receive quetiapine as treatment for delirium.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A randomized group will receive placebo, and not quetiapine.
Intervention Type
Drug
Intervention Name(s)
quetiapine
Other Intervention Name(s)
Seroquil
Intervention Description
Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
Primary Outcome Measure Information:
Title
Time to First Resolution of Delirium
Description
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 Outcome Measure Information:
Title
Total ICU Days With Delirium
Description
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
Other Pre-specified Outcome Measures:
Title
Change in Delirium Severity
Description
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.
Time Frame
Baseline and 3 days of study drug initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chani Traube, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
NY Prebyterian Hospital/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy of Quetiapine for Pediatric Delirium

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