Trial Outcomes & Findings for Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression (NCT NCT00361374)

Last Updated: 2014-07-18

Results Overview

Change in score on 17-item Hamilton D depression severity rating scale over 8 weeks of treatment. Scores were obtained every 2 weeks for 8 weeks. The total sum score of the 17 items is used to assess depressive severity. Possible total scores range from 0-52, with a higher score indicating greater depressive severity. Scores of 7 or less are indicative of full remission (i.e. no depression). Scores of 8-15 indicate mild depression; scores of 16-25 indicate moderate depression; scores of 25 or greater indicate severe depression. Mixed model repeated measures analysis (MMRM) was used to examine treatment group effect on changes from baseline to week 8 in Hamilton D scores. Models included subjects as a random effect, and treatment group and study week as fixed effects. An auto-regressive covariance structure was used because it provided the best fit to the data. Site and baseline score were included as covariates in all models.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

196 participants

Primary outcome timeframe

8 weeks

Results posted on

2014-07-18

Participant Flow

196 adults with MDD were recruited from 05/18/06 to 06/30/11 at Massachusetts General Hospital and Cedars-Sinai Medical Center.

Participant milestones

Participant milestones
Measure	Eicosapentaenoic Acid (EPA) Eicosapentaenoic acid (EPA) Omega-3, 1g/day eicosapentaenoic acid: 1 gram/day	Docosahexaenoic Acid (DHA) Docosahexaenoic acid (DHA) Omega-3, 1g/day docosahexaenoic acid: 1 gram/day	Placebo Placebo capsule (980mg soybean oil) Placebo: 980 milligram/day
Overall Study STARTED	66	65	65
Overall Study COMPLETED	51	50	53
Overall Study NOT COMPLETED	15	15	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eicosapentaenoic Acid (EPA) n=60 Participants Eicosapentaenoic acid (EPA) Omega-3, 1g/day eicosapentaenoic acid: 1 gram/day	Docosahexaenoic Acid (DHA) n=58 Participants Docosahexaenoic acid (DHA) Omega-3, 1g/day docosahexaenoic acid: 1 gram/day	Placebo n=59 Participants Placebo capsule (980mg soybean oil) Placebo: 980 milligram/day	Total n=177 Participants Total of all reporting groups
Age, Continuous	45.8 years STANDARD_DEVIATION 12.5 • n=99 Participants	46.2 years STANDARD_DEVIATION 11.8 • n=107 Participants	45.0 years STANDARD_DEVIATION 12.1 • n=206 Participants	45.8 years STANDARD_DEVIATION 12.5 • n=7 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=99 Participants	50 Participants n=107 Participants	54 Participants n=206 Participants	157 Participants n=7 Participants
Age, Categorical >=65 years	7 Participants n=99 Participants	8 Participants n=107 Participants	5 Participants n=206 Participants	20 Participants n=7 Participants
Sex: Female, Male Female	38 Participants n=99 Participants	32 Participants n=107 Participants	35 Participants n=206 Participants	105 Participants n=7 Participants
Sex: Female, Male Male	22 Participants n=99 Participants	26 Participants n=107 Participants	24 Participants n=206 Participants	72 Participants n=7 Participants
Region of Enrollment United States	60 participants n=99 Participants	58 participants n=107 Participants	59 participants n=206 Participants	177 participants n=7 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: We randomized 196 of 389 screened patients. Nineteen subjects dropped out before completing at least one post-baseline visit, leaving 177 evaluable subjects

Outcome measures

Outcome measures
Measure	Eicosapentaenoic Acid (EPA) n=60 Participants Eicosapentaenoic acid (EPA) Omega-3, 1g/day eicosapentaenoic acid: 1 gram/day	Docosahexaenoic Acid (DHA) n=58 Participants Docosahexaenoic acid (DHA) Omega-3, 1g/day docosahexaenoic acid: 1 gram/day	Placebo n=59 Participants Placebo capsule (980mg soybean oil) Placebo: 980 milligram/day
Score on a Depression Severity Rating Scale Over Eight Weeks	-10.34 units on a scale Standard Error 0.62	-9.26 units on a scale Standard Error 0.62	-9.49 units on a scale Standard Error 0.61

Adverse Events

Eicosapentaenoic Acid (EPA)

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Docosahexaenoic Acid (DHA)

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr David Mischoulon, Director of Research, Depression Clinical and Research Program

Massachusetts General Hospital

Phone: 617-724-5198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Eicosapentaenoic Acid (EPA) n=60 participants at risk Eicosapentaenoic acid (EPA) Omega-3, 1g/day eicosapentaenoic acid: 1 gram/day	Docosahexaenoic Acid (DHA) n=58 participants at risk Docosahexaenoic acid (DHA) Omega-3, 1g/day docosahexaenoic acid: 1 gram/day	Placebo n=59 participants at risk Placebo capsule (980mg soybean oil) Placebo: 980 milligram/day
Gastrointestinal disorders Diarrhea	10.0% 6/60 • Number of events 6 • Adverse events were collected over the 8 weeks of the study period.	13.8% 8/58 • Number of events 8 • Adverse events were collected over the 8 weeks of the study period.	18.6% 11/59 • Number of events 11 • Adverse events were collected over the 8 weeks of the study period.
Gastrointestinal disorders Constipation	13.3% 8/60 • Number of events 8 • Adverse events were collected over the 8 weeks of the study period.	13.8% 8/58 • Number of events 8 • Adverse events were collected over the 8 weeks of the study period.	0.00% 0/59 • Adverse events were collected over the 8 weeks of the study period.
Gastrointestinal disorders Dry mouth	13.3% 8/60 • Number of events 8 • Adverse events were collected over the 8 weeks of the study period.	12.1% 7/58 • Number of events 7 • Adverse events were collected over the 8 weeks of the study period.	6.8% 4/59 • Number of events 4 • Adverse events were collected over the 8 weeks of the study period.
Gastrointestinal disorders Nausea or vomiting	11.7% 7/60 • Number of events 7 • Adverse events were collected over the 8 weeks of the study period.	13.8% 8/58 • Number of events 8 • Adverse events were collected over the 8 weeks of the study period.	8.5% 5/59 • Number of events 5 • Adverse events were collected over the 8 weeks of the study period.
Cardiac disorders Palpitations	13.3% 8/60 • Number of events 8 • Adverse events were collected over the 8 weeks of the study period.	12.1% 7/58 • Number of events 7 • Adverse events were collected over the 8 weeks of the study period.	3.4% 2/59 • Number of events 2 • Adverse events were collected over the 8 weeks of the study period.
Cardiac disorders Dizziness on standing	8.3% 5/60 • Number of events 5 • Adverse events were collected over the 8 weeks of the study period.	12.1% 7/58 • Number of events 7 • Adverse events were collected over the 8 weeks of the study period.	6.8% 4/59 • Number of events 4 • Adverse events were collected over the 8 weeks of the study period.
Cardiac disorders Chest pain	0.00% 0/60 • Adverse events were collected over the 8 weeks of the study period.	1.7% 1/58 • Number of events 1 • Adverse events were collected over the 8 weeks of the study period.	1.7% 1/59 • Number of events 1 • Adverse events were collected over the 8 weeks of the study period.
Skin and subcutaneous tissue disorders Rash	3.3% 2/60 • Number of events 2 • Adverse events were collected over the 8 weeks of the study period.	5.2% 3/58 • Number of events 3 • Adverse events were collected over the 8 weeks of the study period.	3.4% 2/59 • Number of events 2 • Adverse events were collected over the 8 weeks of the study period.
Skin and subcutaneous tissue disorders Increased perspiration	8.3% 5/60 • Number of events 5 • Adverse events were collected over the 8 weeks of the study period.	8.6% 5/58 • Number of events 5 • Adverse events were collected over the 8 weeks of the study period.	6.8% 4/59 • Number of events 4 • Adverse events were collected over the 8 weeks of the study period.
Skin and subcutaneous tissue disorders Itching	6.7% 4/60 • Number of events 4 • Adverse events were collected over the 8 weeks of the study period.	10.3% 6/58 • Number of events 6 • Adverse events were collected over the 8 weeks of the study period.	6.8% 4/59 • Number of events 4 • Adverse events were collected over the 8 weeks of the study period.
Skin and subcutaneous tissue disorders Dry skin	10.0% 6/60 • Number of events 6 • Adverse events were collected over the 8 weeks of the study period.	12.1% 7/58 • Number of events 7 • Adverse events were collected over the 8 weeks of the study period.	13.6% 8/59 • Number of events 8 • Adverse events were collected over the 8 weeks of the study period.
Nervous system disorders Headache	13.3% 8/60 • Number of events 8 • Adverse events were collected over the 8 weeks of the study period.	20.7% 12/58 • Number of events 12 • Adverse events were collected over the 8 weeks of the study period.	20.3% 12/59 • Number of events 12 • Adverse events were collected over the 8 weeks of the study period.
Nervous system disorders Tremors	1.7% 1/60 • Number of events 1 • Adverse events were collected over the 8 weeks of the study period.	8.6% 5/58 • Number of events 5 • Adverse events were collected over the 8 weeks of the study period.	0.00% 0/59 • Adverse events were collected over the 8 weeks of the study period.
Nervous system disorders Poor coordination	3.3% 2/60 • Number of events 2 • Adverse events were collected over the 8 weeks of the study period.	10.3% 6/58 • Number of events 6 • Adverse events were collected over the 8 weeks of the study period.	6.8% 4/59 • Number of events 4 • Adverse events were collected over the 8 weeks of the study period.
Nervous system disorders Dizziness	1.7% 1/60 • Number of events 1 • Adverse events were collected over the 8 weeks of the study period.	12.1% 7/58 • Number of events 7 • Adverse events were collected over the 8 weeks of the study period.	6.8% 4/59 • Number of events 4 • Adverse events were collected over the 8 weeks of the study period.
Eye disorders Blurred vision	8.3% 5/60 • Number of events 5 • Adverse events were collected over the 8 weeks of the study period.	8.6% 5/58 • Number of events 5 • Adverse events were collected over the 8 weeks of the study period.	11.9% 7/59 • Number of events 7 • Adverse events were collected over the 8 weeks of the study period.
Ear and labyrinth disorders Ringing in ears	6.7% 4/60 • Number of events 4 • Adverse events were collected over the 8 weeks of the study period.	3.4% 2/58 • Number of events 2 • Adverse events were collected over the 8 weeks of the study period.	3.4% 2/59 • Number of events 2 • Adverse events were collected over the 8 weeks of the study period.
Renal and urinary disorders Difficulty urinating	0.00% 0/60 • Adverse events were collected over the 8 weeks of the study period.	3.4% 2/58 • Number of events 2 • Adverse events were collected over the 8 weeks of the study period.	0.00% 0/59 • Adverse events were collected over the 8 weeks of the study period.
Renal and urinary disorders Painful urination	0.00% 0/60 • Adverse events were collected over the 8 weeks of the study period.	1.7% 1/58 • Number of events 1 • Adverse events were collected over the 8 weeks of the study period.	0.00% 0/59 • Adverse events were collected over the 8 weeks of the study period.
Renal and urinary disorders Frequent urination	15.0% 9/60 • Number of events 9 • Adverse events were collected over the 8 weeks of the study period.	8.6% 5/58 • Number of events 5 • Adverse events were collected over the 8 weeks of the study period.	5.1% 3/59 • Number of events 3 • Adverse events were collected over the 8 weeks of the study period.
Reproductive system and breast disorders Menstrual irregularity	3.3% 2/60 • Number of events 2 • Adverse events were collected over the 8 weeks of the study period.	5.2% 3/58 • Number of events 3 • Adverse events were collected over the 8 weeks of the study period.	5.1% 3/59 • Number of events 3 • Adverse events were collected over the 8 weeks of the study period.
Psychiatric disorders Difficulty sleeping	30.0% 18/60 • Number of events 18 • Adverse events were collected over the 8 weeks of the study period.	19.0% 11/58 • Number of events 11 • Adverse events were collected over the 8 weeks of the study period.	20.3% 12/59 • Number of events 12 • Adverse events were collected over the 8 weeks of the study period.
Psychiatric disorders Sleeping too much	6.7% 4/60 • Number of events 4 • Adverse events were collected over the 8 weeks of the study period.	12.1% 7/58 • Number of events 7 • Adverse events were collected over the 8 weeks of the study period.	10.2% 6/59 • Number of events 6 • Adverse events were collected over the 8 weeks of the study period.
Psychiatric disorders Loss of sexual desire	11.7% 7/60 • Number of events 7 • Adverse events were collected over the 8 weeks of the study period.	15.5% 9/58 • Number of events 9 • Adverse events were collected over the 8 weeks of the study period.	20.3% 12/59 • Number of events 12 • Adverse events were collected over the 8 weeks of the study period.
Psychiatric disorders Trouble achieving orgasm	10.0% 6/60 • Number of events 6 • Adverse events were collected over the 8 weeks of the study period.	5.2% 3/58 • Number of events 3 • Adverse events were collected over the 8 weeks of the study period.	3.4% 2/59 • Number of events 2 • Adverse events were collected over the 8 weeks of the study period.
Psychiatric disorders Trouble with erections	1.7% 1/60 • Number of events 1 • Adverse events were collected over the 8 weeks of the study period.	0.00% 0/58 • Adverse events were collected over the 8 weeks of the study period.	1.7% 1/59 • Number of events 1 • Adverse events were collected over the 8 weeks of the study period.
Psychiatric disorders Anxiety	16.7% 10/60 • Number of events 10 • Adverse events were collected over the 8 weeks of the study period.	24.1% 14/58 • Number of events 14 • Adverse events were collected over the 8 weeks of the study period.	23.7% 14/59 • Number of events 14 • Adverse events were collected over the 8 weeks of the study period.
Psychiatric disorders Poor concentration	21.7% 13/60 • Number of events 13 • Adverse events were collected over the 8 weeks of the study period.	20.7% 12/58 • Number of events 12 • Adverse events were collected over the 8 weeks of the study period.	23.7% 14/59 • Number of events 14 • Adverse events were collected over the 8 weeks of the study period.
Psychiatric disorders General malaise	8.3% 5/60 • Number of events 5 • Adverse events were collected over the 8 weeks of the study period.	12.1% 7/58 • Number of events 7 • Adverse events were collected over the 8 weeks of the study period.	20.3% 12/59 • Number of events 12 • Adverse events were collected over the 8 weeks of the study period.
Psychiatric disorders Restlessness	6.7% 4/60 • Number of events 4 • Adverse events were collected over the 8 weeks of the study period.	13.8% 8/58 • Number of events 8 • Adverse events were collected over the 8 weeks of the study period.	20.3% 12/59 • Number of events 12 • Adverse events were collected over the 8 weeks of the study period.
Psychiatric disorders Fatigue	23.3% 14/60 • Number of events 14 • Adverse events were collected over the 8 weeks of the study period.	22.4% 13/58 • Number of events 13 • Adverse events were collected over the 8 weeks of the study period.	15.3% 9/59 • Number of events 9 • Adverse events were collected over the 8 weeks of the study period.
Psychiatric disorders Decreased energy	26.7% 16/60 • Number of events 16 • Adverse events were collected over the 8 weeks of the study period.	20.7% 12/58 • Number of events 12 • Adverse events were collected over the 8 weeks of the study period.	22.0% 13/59 • Number of events 13 • Adverse events were collected over the 8 weeks of the study period.