Trial Outcomes & Findings for Omega-3 for Depression and Other Cardiac Risk Factors - 2 (NCT NCT02021669)
NCT ID: NCT02021669
Last Updated: 2019-09-04
Results Overview
The BDI-II is a 21-item self-report inventory of depression symptoms. The minimum and maximum values for the BDI-II are (0-63). For both instruments, the higher the scores, the greater the severity of depression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
144 participants
Primary outcome timeframe
Change from baseline to 10 weeks (post-treatment)
Results posted on
2019-09-04
Participant Flow
Participant milestones
| Measure |
Omega-3 Supplement
Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks
Omega-3 supplement: Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks
|
Placebo
Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
Placebo: Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
73
|
|
Overall Study
COMPLETED
|
64
|
70
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Omega-3 for Depression and Other Cardiac Risk Factors - 2
Baseline characteristics by cohort
| Measure |
Total
n=144 Participants
Total of all reporting groups
|
Omega-3 Supplement
n=71 Participants
Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks
Omega-3 supplement: Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks
|
Placebo
n=73 Participants
Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
Placebo: Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
95 Participants
n=5 Participants
|
49 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=5 Participants
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
48 Participants
n=5 Participants
|
21 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=5 Participants
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
144 participants
n=5 Participants
|
71 participants
n=5 Participants
|
73 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 10 weeks (post-treatment)The BDI-II is a 21-item self-report inventory of depression symptoms. The minimum and maximum values for the BDI-II are (0-63). For both instruments, the higher the scores, the greater the severity of depression.
Outcome measures
| Measure |
Omega-3 Supplement
n=71 Participants
Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks
Omega-3 supplement: Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks
|
Placebo
n=73 Participants
Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
Placebo: Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
|
|---|---|---|
|
Beck Depression Inventory-II (BDI-II)
Baseline
|
29.9 score on a scale
Standard Deviation 9.0
|
29.1 score on a scale
Standard Deviation 8.8
|
|
Beck Depression Inventory-II (BDI-II)
Post Treatment (10 Weeks)
|
11.0 score on a scale
Standard Deviation 9.9
|
9.1 score on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Change from baseline to 10 weeks (post-treatment)The HAM-D, 17 is a 17-item, observer-rated measure of depression symptoms. The minimum and maximum values for the HAM-D, (0-52). For both instruments, the higher the scores, the greater the severity of depression.
Outcome measures
| Measure |
Omega-3 Supplement
n=71 Participants
Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks
Omega-3 supplement: Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks
|
Placebo
n=73 Participants
Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
Placebo: Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
|
|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D, 17)
Baseline
|
17.4 score on a scale
Standard Deviation 5.4
|
17.0 score on a scale
Standard Deviation 5.0
|
|
Hamilton Depression Rating Scale (HAM-D, 17)
Post Treatment (10 Weeks)
|
7.1 score on a scale
Standard Deviation 7.0
|
6.2 score on a scale
Standard Deviation 5.5
|
Adverse Events
Omega-3 Supplement
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omega-3 Supplement
n=71 participants at risk
Two grams of the EPA form of omega-3 plus 50 mg of sertraline daily for 10 weeks
Omega-3 supplement: Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks
|
Placebo
n=73 participants at risk
Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
Placebo: Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
|
|---|---|---|
|
General disorders
Nausea
|
21.1%
15/71 • Number of events 15 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
15.1%
11/73 • Number of events 11 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
Gastrointestinal disorders
Diarrhea
|
9.9%
7/71 • Number of events 7 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
20.5%
15/73 • Number of events 15 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
Gastrointestinal disorders
Constipation
|
5.6%
4/71 • Number of events 4 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
4.1%
3/73 • Number of events 3 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
Gastrointestinal disorders
Increased flatulence
|
2.8%
2/71 • Number of events 2 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
4.1%
3/73 • Number of events 3 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
General disorders
Increased sleepiness
|
11.3%
8/71 • Number of events 8 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
6.8%
5/73 • Number of events 5 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
General disorders
Fatigue
|
5.6%
4/71 • Number of events 4 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
4.1%
3/73 • Number of events 3 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
General disorders
Dizziness
|
4.2%
3/71 • Number of events 3 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
2.7%
2/73 • Number of events 2 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
General disorders
Insomnia
|
2.8%
2/71 • Number of events 2 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
0.00%
0/73 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
Nervous system disorders
Hand Tremors
|
2.8%
2/71 • Number of events 2 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
4.1%
3/73 • Number of events 3 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
General disorders
Decreased sexual interest/performance
|
1.4%
1/71 • Number of events 1 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
2.7%
2/73 • Number of events 2 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
Social circumstances
Less emotionally responsive
|
4.2%
3/71 • Number of events 3 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
2.7%
2/73 • Number of events 2 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
General disorders
Headaches
|
4.2%
3/71 • Number of events 3 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
8.2%
6/73 • Number of events 6 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
Psychiatric disorders
Increased anxiety
|
4.2%
3/71 • Number of events 3 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
2.7%
2/73 • Number of events 2 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
Psychiatric disorders
Agitation
|
4.2%
3/71 • Number of events 3 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
1.4%
1/73 • Number of events 1 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
General disorders
Increased sweating
|
2.8%
2/71 • Number of events 2 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
4.1%
3/73 • Number of events 3 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
Gastrointestinal disorders
Decreased appetite
|
1.4%
1/71 • Number of events 1 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
1.4%
1/73 • Number of events 1 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
General disorders
Bad taste in mouth
|
1.4%
1/71 • Number of events 1 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
4.1%
3/73 • Number of events 3 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
|
Gastrointestinal disorders
Burping
|
2.8%
2/71 • Number of events 2 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
0.00%
0/73 • Each participant was followed for fourteen weeks (ten weeks of treatment plus a final call 4 weeks after the end of treatment)
|
Additional Information
Robert M. Carney, Ph.D
Washington University School of Medicine
Phone: 314-286-1305
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place