Trial Outcomes & Findings for Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents (NCT NCT00592683)
NCT ID: NCT00592683
Last Updated: 2012-04-06
Results Overview
The YMRS is used to evaluate symptoms of mania in children and adolescents. Items are rated from 0-4 or 0-8, with higher scores indicating greater severity. The minimum total score (least severe) is 0, and the maximum total score (most severe) is 60.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
weekly for 1st 6 weeks then biweekly
Results posted on
2012-04-06
Participant Flow
Participant milestones
| Measure |
Aripiprazole + Fish Oil
treatment with aripiprazole + fish oil
|
Aripiprazole + Placebo
treatment with aripiprazole + placebo
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Aripiprazole + Fish Oil
treatment with aripiprazole + fish oil
|
Aripiprazole + Placebo
treatment with aripiprazole + placebo
|
|---|---|---|
|
Overall Study
Found ineligible
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Study drug expired
|
1
|
0
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents
Baseline characteristics by cohort
| Measure |
Aripiprazole + Fish Oil
n=10 Participants
treatment with aripiprazole + fish oil
|
Aripiprazole + Placebo
n=10 Participants
treatment with aripiprazole + placebo
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age Continuous
|
10.8 years
STANDARD_DEVIATION 3.65 • n=93 Participants
|
11 years
STANDARD_DEVIATION 3.71 • n=4 Participants
|
10.9 years
STANDARD_DEVIATION 3.58 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
20 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: weekly for 1st 6 weeks then biweeklyPopulation: 14 subjects came in for week 12 assessments - included in final analysis.
The YMRS is used to evaluate symptoms of mania in children and adolescents. Items are rated from 0-4 or 0-8, with higher scores indicating greater severity. The minimum total score (least severe) is 0, and the maximum total score (most severe) is 60.
Outcome measures
| Measure |
Aripiprazole + Fish Oil
n=8 Participants
treatment with aripiprazole + fish oil
|
Aripiprazole + Placebo
n=6 Participants
treatment with aripiprazole + placebo
|
|---|---|---|
|
Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)
|
9.5 Units on a scale
Standard Deviation 7.78
|
8.5 Units on a scale
Standard Deviation 7.40
|
SECONDARY outcome
Timeframe: weekly for first 6 weeks then biweeklyPopulation: 14 subjects came in for week 12 assessments - included in final analysis.
The DSM-IV Mania Symptom Checklist is used to evaluate symptoms of mania. Item scores range from 0-3, with larger scores indicating greater severity. With 33 items, the maximum (most severe) score possible is 99, with the minimum (least severe) score possible being 0.
Outcome measures
| Measure |
Aripiprazole + Fish Oil
n=8 Participants
treatment with aripiprazole + fish oil
|
Aripiprazole + Placebo
n=6 Participants
treatment with aripiprazole + placebo
|
|---|---|---|
|
DSM-IV Mania Symptom Checklist
|
5.25 units on a scale
Standard Deviation 5.23
|
5 units on a scale
Standard Deviation 3.16
|
Adverse Events
Aripiprazole + Fish Oil
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Aripiprazole + Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aripiprazole + Fish Oil
n=10 participants at risk
treatment with aripiprazole + fish oil
|
Aripiprazole + Placebo
n=10 participants at risk
treatment with aripiprazole + placebo
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash (poison ivy)
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
restless
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
rhinorrhea
|
20.0%
2/10 • Number of events 4
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
saddness/crying
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
sedation
|
20.0%
2/10 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
skin rash
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
General disorders
slurred speech
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
sore throat
|
10.0%
1/10 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
General disorders
sores in mouth (healed)
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
sprained finger
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
stomachache
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
General disorders
tiredness
|
70.0%
7/10 • Number of events 16
|
40.0%
4/10 • Number of events 7
|
|
General disorders
transient facial flushing
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
weight gain
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
chest pain with inspiration
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
General disorders
cold symptoms
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
|
General disorders
decreased energy
|
20.0%
2/10 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
General disorders
decreased appetite
|
0.00%
0/10
|
20.0%
2/10 • Number of events 3
|
|
Gastrointestinal disorders
diarrhea
|
20.0%
2/10 • Number of events 4
|
0.00%
0/10
|
|
Ear and labyrinth disorders
dizziness
|
0.00%
0/10
|
10.0%
1/10 • Number of events 3
|
|
General disorders
dry mouth
|
20.0%
2/10 • Number of events 3
|
0.00%
0/10
|
|
Ear and labyrinth disorders
ear infection
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
flatulence
|
10.0%
1/10 • Number of events 2
|
0.00%
0/10
|
|
General disorders
hand tremor
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
headache
|
0.00%
0/10
|
30.0%
3/10 • Number of events 5
|
|
Gastrointestinal disorders
heartburn
|
0.00%
0/10
|
10.0%
1/10 • Number of events 3
|
|
General disorders
increased appetite
|
10.0%
1/10 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
|
General disorders
increased sleep
|
10.0%
1/10 • Number of events 2
|
0.00%
0/10
|
|
General disorders
irritability
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
left ankle swelling (injury)
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Reproductive system and breast disorders
period 1 week late
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
nausea/vomiting
|
30.0%
3/10 • Number of events 4
|
40.0%
4/10 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place