Trial Outcomes & Findings for Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania (NCT NCT00917501)
NCT ID: NCT00917501
Last Updated: 2019-11-13
Results Overview
Change in Children's Depression Rating Scale-revised (CDRS-R) Total Score from Baseline to 12 weeks CDRS-R score ranges from 17 (i.e., not depressed) to 113 (i.e., severe depression)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2019-11-13
Participant Flow
Participant milestones
| Measure |
Placebo
Olive oil - 3 capsules/day
|
Omega-3
Fish oil - 3 capsules/day
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
26
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Olive oil - 3 capsules/day
|
Omega-3
Fish oil - 3 capsules/day
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
trouble swollowing capsules
|
0
|
1
|
Baseline Characteristics
Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania
Baseline characteristics by cohort
| Measure |
Placebo
n=29 Participants
Olive oil - 3 capsules/day
|
Omega-3
n=26 Participants
Fish oil - 3 capsules/day
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.4 Years
STANDARD_DEVIATION 3.3 • n=99 Participants
|
13 Years
STANDARD_DEVIATION 4.5 • n=107 Participants
|
13.2 Years
STANDARD_DEVIATION 3.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
26 participants
n=107 Participants
|
55 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksChange in Children's Depression Rating Scale-revised (CDRS-R) Total Score from Baseline to 12 weeks CDRS-R score ranges from 17 (i.e., not depressed) to 113 (i.e., severe depression)
Outcome measures
| Measure |
Placebo
n=29 Participants
Olive oil - 3 capsules/day
|
Omega-3
n=26 Participants
Fish oil - 3 capsules/day
|
|---|---|---|
|
Change From Baseline in Depression Symptom Severity at 12 Weeks
|
18 Total score on CDRS-R
Standard Deviation 9.7
|
17.7 Total score on CDRS-R
Standard Deviation 11
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Omega-3
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=29 participants at risk
Olive oil - 3 capsules/day
|
Omega-3
n=26 participants at risk
Fish oil - 3 capsules/day
|
|---|---|---|
|
General disorders
Muscle Cramps
|
0.00%
0/29
|
30.8%
8/26 • Number of events 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place