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Trial record 11 of 450 for:    QUETIAPINE

Efficacy of Quetiapine for Pediatric Delirium

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ClinicalTrials.gov Identifier: NCT02056171
Recruitment Status : Terminated (Unable to recruit subjects at our site within the past year.)
First Posted : February 5, 2014
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Delirium
Interventions Drug: quetiapine
Other: Placebo
Enrollment 6
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.
Pre-assignment Details  
Arm/Group Title Quetiapine Placebo
Hide 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
Arm/Group Title Quetiapine Placebo Total
Hide 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 Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
<=18 years
3
 100.0%
3
 100.0%
6
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants
4
(3 to 18)
3
(2 to 3)
3
(2 to 18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
1
  33.3%
2
  66.7%
3
  50.0%
Male
2
  66.7%
1
  33.3%
3
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 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%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  66.7%
0
   0.0%
2
  33.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  33.3%
1
  16.7%
White
1
  33.3%
2
  66.7%
3
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 6 participants
3
 100.0%
3
 100.0%
6
 100.0%
1.Primary Outcome
Title Time to First Resolution of Delirium
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants are included in analysis.
Arm/Group Title Quetiapine Placebo
Hide 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.

Overall Number of Participants Analyzed 3 3
Mean (Full Range)
Unit of Measure: days
8
(4 to 10)
7
(2 to 10)
2.Secondary Outcome
Title Total ICU Days With Delirium
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Placebo
Hide 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.

Overall Number of Participants Analyzed 3 3
Mean (Full Range)
Unit of Measure: days
8
(6 to 10)
7
(2 to 10)
3.Other Pre-specified Outcome
Title Change in Delirium Severity
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 3 3
Median (Full Range)
Unit of Measure: units on a scale
1
(1 to 2)
0
(0 to 1)
Time Frame 22 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine Placebo
Hide 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 (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      1/3 (33.33%)    
Musculoskeletal and connective tissue disorders     
movement disorder   0/3 (0.00%)  0 1/3 (33.33%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Quetiapine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)    
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chani Traube
Organization: Weill Cornell Medicine
Phone: 212-746-3056
EMail: chr9008@med.cornell.edu
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02056171     History of Changes
Other Study ID Numbers: 1309014323
First Submitted: February 4, 2014
First Posted: February 5, 2014
Results First Submitted: September 29, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017