Trial Outcomes & Findings for Efficacy of Quetiapine for Pediatric Delirium (NCT NCT02056171)

NCT ID: NCT02056171

Last Updated: 2017-12-13

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Within the first 10 days after study enrollment

Results posted on

2017-12-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Quetiapine 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.	Placebo 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 Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Quetiapine for Pediatric Delirium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quetiapine n=3 Participants 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.	Placebo n=3 Participants 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 n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	4 years n=5 Participants	3 years n=7 Participants	3 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within the first 10 days after study enrollment

Population: All participants are included in analysis.

Outcome measures

Outcome measures
Measure	Quetiapine n=3 Participants 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.	Placebo n=3 Participants 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.
Time to First Resolution of Delirium	8 days Interval 4.0 to 10.0	7 days Interval 2.0 to 10.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Quetiapine n=3 Participants 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.	Placebo n=3 Participants 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 ICU Days With Delirium	8 days Interval 6.0 to 10.0	7 days Interval 2.0 to 10.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 days of study drug initiation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Quetiapine n=3 Participants 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.	Placebo n=3 Participants 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.
Change in Delirium Severity	1 units on a scale Interval 1.0 to 2.0	0 units on a scale Interval 0.0 to 1.0

Adverse Events

Quetiapine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Quetiapine n=3 participants at risk 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.	Placebo n=3 participants at risk 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.
Musculoskeletal and connective tissue disorders movement disorder	0.00% 0/3 • 22 months	33.3% 1/3 • Number of events 1 • 22 months

Other adverse events

Adverse event data not reported

Additional Information

Chani Traube

Weill Cornell Medicine

Phone: 212-746-3056

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place