Trial Outcomes & Findings for Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder (NCT NCT00181883)
NCT ID: NCT00181883
Last Updated: 2012-04-06
Results Overview
The Y-MRS is used to evaluate mania symptoms in children and adolescents. Items on the scale are rated from 0-4 or 0-8, with higher values indicating greater severity. The minimum (least severe) total score is 0, with the maximum (most severe) score is 60.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Baseline to 8 weeks
Results posted on
2012-04-06
Participant Flow
Participant milestones
| Measure |
Quetiapine
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Quetiapine
|
|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Treatment Limiting AEs
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Quetiapine
n=30 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
5.2 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksThe Y-MRS is used to evaluate mania symptoms in children and adolescents. Items on the scale are rated from 0-4 or 0-8, with higher values indicating greater severity. The minimum (least severe) total score is 0, with the maximum (most severe) score is 60.
Outcome measures
| Measure |
Quetiapine
n=30 Participants
|
|---|---|
|
Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score
|
-14.5 Units on a scale
Standard Deviation 11.4
|
Adverse Events
Quetiapine
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Quetiapine
n=30 participants at risk
|
|---|---|
|
Psychiatric disorders
suicidal ideation
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Quetiapine
n=30 participants at risk
|
|---|---|
|
Injury, poisoning and procedural complications
chin/elbow abrasions
|
3.3%
1/30 • Number of events 1
|
|
Injury, poisoning and procedural complications
injury (fall)
|
3.3%
1/30 • Number of events 1
|
|
General disorders
agitation
|
6.7%
2/30 • Number of events 2
|
|
General disorders
anxious/figety
|
3.3%
1/30 • Number of events 1
|
|
General disorders
blurry vision
|
3.3%
1/30 • Number of events 1
|
|
General disorders
cold symptoms
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
congested
|
20.0%
6/30 • Number of events 8
|
|
Gastrointestinal disorders
constipation
|
10.0%
3/30 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
6.7%
2/30 • Number of events 3
|
|
General disorders
daytime sleepiness
|
10.0%
3/30 • Number of events 5
|
|
General disorders
depressed mood
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
3.3%
1/30 • Number of events 1
|
|
General disorders
enlarged gland, right side of neck
|
3.3%
1/30 • Number of events 1
|
|
General disorders
enuresis
|
13.3%
4/30 • Number of events 6
|
|
General disorders
epistasis (nose bleeding)
|
3.3%
1/30 • Number of events 1
|
|
General disorders
fever
|
6.7%
2/30 • Number of events 3
|
|
General disorders
flu
|
3.3%
1/30 • Number of events 1
|
|
General disorders
headache
|
13.3%
4/30 • Number of events 8
|
|
General disorders
increased appetite
|
13.3%
4/30 • Number of events 11
|
|
General disorders
insect bite
|
3.3%
1/30 • Number of events 1
|
|
General disorders
irritable
|
3.3%
1/30 • Number of events 2
|
|
General disorders
lethargy
|
6.7%
2/30 • Number of events 3
|
|
General disorders
minor burn on arm
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
6.7%
2/30 • Number of events 2
|
|
General disorders
pallor
|
3.3%
1/30 • Number of events 1
|
|
General disorders
perseveration
|
3.3%
1/30 • Number of events 1
|
|
General disorders
sedation
|
6.7%
2/30 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
6.7%
2/30 • Number of events 2
|
|
General disorders
sleepiness
|
26.7%
8/30 • Number of events 13
|
|
General disorders
slurred speech
|
3.3%
1/30 • Number of events 3
|
|
General disorders
somnolence
|
3.3%
1/30 • Number of events 1
|
|
General disorders
sore throat
|
10.0%
3/30 • Number of events 5
|
|
Gastrointestinal disorders
stomach ache
|
13.3%
4/30 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
sunburn
|
3.3%
1/30 • Number of events 1
|
|
General disorders
teary
|
3.3%
1/30 • Number of events 2
|
|
General disorders
thirsty/dry mouth
|
3.3%
1/30 • Number of events 1
|
|
General disorders
tiredness
|
20.0%
6/30 • Number of events 11
|
|
Gastrointestinal disorders
vomiting
|
10.0%
3/30 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place