Efficacy of Quetiapine for Pediatric Delirium

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02056171
• Collaborator: (none)
• Enrollment: 6
• Locations: 2
• Arms: 2
• Duration (Months): 21.1
• Patients Per Site: 3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Delirium	Drug: quetiapine; Other: Placebo	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Quetiapine for Pediatric Delirium
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quetiapine A randomized group will receive quetiapine as treatment for delirium.	Drug: quetiapine; Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.; Other Names: Seroquil
Placebo Comparator: Placebo A randomized group will receive placebo, and not quetiapine.	Other: Placebo; Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.

Outcome Measures

Primary Outcome Measures

1. Time to First Resolution of Delirium [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 Outcome Measures

1. Total ICU Days With Delirium [Within 10 days after study enrollment]

   Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period.

Other Outcome Measures

1. Change in Delirium Severity [Baseline and 3 days of study drug initiation]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 22 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032
2	NY Prebyterian Hospital/Weill Cornell Medical Center	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Chani Traube, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT02056171
• Other Study ID Numbers: 1309014323
• First Posted: Feb 5, 2014
• Last Update Posted: Dec 13, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Weill Medical College of Cornell University: delirium; pediatrics; critical care; quetiapine
• Additional relevant MeSH terms: Delirium; Quetiapine Fumarate

Study Results

Participant Flow

Recruitment Details	Six participants were enrolled over 22 months between March 2015 and December 2016. The first participant was enrolled in March 2015 and the last participant was enrolled in December 2015.

Arm/Group Title	Quetiapine	Placebo
Arm/Group Description	A randomized group will receive quetiapine as treatment for delirium. Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.	A randomized group will receive placebo, and not quetiapine. Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
Period Title: Overall Study
STARTED	3	3
COMPLETED	3	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Quetiapine	Placebo	Total
Arm/Group Description	A randomized group will receive quetiapine as treatment for delirium. Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.	A randomized group will receive placebo, and not quetiapine. Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.	Total of all reporting groups
Overall Participants	3	3	6
Age (Count of Participants)
<=18 years	3 100%	3 100%	6 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	4	3	3
Sex: Female, Male (Count of Participants)
Female	1 33.3%	2 66.7%	3 50%
Male	2 66.7%	1 33.3%	3 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 33.3%	1 33.3%	2 33.3%
Not Hispanic or Latino	2 66.7%	2 66.7%	4 66.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 66.7%	0 0%	2 33.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 33.3%	1 16.7%
White	1 33.3%	2 66.7%	3 50%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	3 100%	3 100%	6 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants are included in analysis.

Arm/Group Title	Quetiapine	Placebo
Arm/Group Description	A randomized group will receive quetiapine as treatment for delirium. Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.	A randomized group will receive placebo, and not quetiapine. Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
Measure Participants	3	3
Mean (Full Range) [days]	8	7

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Quetiapine	Placebo
Arm/Group Description	A randomized group will receive quetiapine as treatment for delirium. Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.	A randomized group will receive placebo, and not quetiapine. Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
Measure Participants	3	3
Mean (Full Range) [days]	8	7

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

Change in CAPD score from baseline to day 3. A decrease in total score implies an improvement in delirium. An increase in total score implies worsening delirium.

Arm/Group Title	Quetiapine	Placebo
Arm/Group Description	A randomized group will receive quetiapine as treatment for delirium. Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.	A randomized group will receive placebo, and not quetiapine. Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
Measure Participants	3	3
Median (Full Range) [units on a scale]	1	0

Adverse Events

Time Frame	22 months
Arm/Group Title	Quetiapine		Placebo
Arm/Group Description	A randomized group will receive quetiapine as treatment for delirium. Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.		A randomized group will receive placebo, and not quetiapine. Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
All Cause Mortality
	Quetiapine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)
Serious Adverse Events
	Quetiapine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		1/3 (33.3%)
Musculoskeletal and connective tissue disorders
movement disorder	0/3 (0%)	0	1/3 (33.3%)	1
Other (Not Including Serious) Adverse Events
	Quetiapine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.