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

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ClinicalTrials.gov Identifier: NCT00361374
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : July 18, 2014
Last Update Posted : July 18, 2014
Sponsor:
Collaborators:
Cedars-Sinai Medical Center
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Mischoulon, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Dietary Supplement: eicosapentaenoic acid
Dietary Supplement: docosahexaenoic acid
Drug: Placebo
Enrollment 196
Recruitment Details 196 adults with MDD were recruited from 05/18/06 to 06/30/11 at Massachusetts General Hospital and Cedars-Sinai Medical Center.
Pre-assignment Details  
Arm/Group Title Eicosapentaenoic Acid (EPA) Docosahexaenoic Acid (DHA) Placebo
Hide Arm/Group Description

Eicosapentaenoic acid (EPA) Omega-3, 1g/day

eicosapentaenoic acid: 1 gram/day

Docosahexaenoic acid (DHA) Omega-3, 1g/day

docosahexaenoic acid: 1 gram/day

Placebo capsule (980mg soybean oil)

Placebo: 980 milligram/day

Period Title: Overall Study
Started 66 65 65
Completed 51 50 53
Not Completed 15 15 12
Arm/Group Title Eicosapentaenoic Acid (EPA) Docosahexaenoic Acid (DHA) Placebo Total
Hide Arm/Group Description

Eicosapentaenoic acid (EPA) Omega-3, 1g/day

eicosapentaenoic acid: 1 gram/day

Docosahexaenoic acid (DHA) Omega-3, 1g/day

docosahexaenoic acid: 1 gram/day

Placebo capsule (980mg soybean oil)

Placebo: 980 milligram/day

Total of all reporting groups
Overall Number of Baseline Participants 60 58 59 177
Hide Baseline Analysis Population Description
We randomized 196 of 389 screened patients. Nineteen subjects dropped out before completing at least one post-baseline visit, leaving 177 evaluable subjects for analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 58 participants 59 participants 177 participants
45.8  (12.5) 46.2  (11.8) 45.0  (12.1) 45.8  (12.5)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 58 participants 59 participants 177 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
53
  88.3%
50
  86.2%
54
  91.5%
157
  88.7%
>=65 years
7
  11.7%
8
  13.8%
5
   8.5%
20
  11.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 58 participants 59 participants 177 participants
Female
38
  63.3%
32
  55.2%
35
  59.3%
105
  59.3%
Male
22
  36.7%
26
  44.8%
24
  40.7%
72
  40.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 58 participants 59 participants 177 participants
60 58 59 177
1.Primary Outcome
Title Score on a Depression Severity Rating Scale Over Eight Weeks
Hide Description 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.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We randomized 196 of 389 screened patients. Nineteen subjects dropped out before completing at least one post-baseline visit, leaving 177 evaluable subjects
Arm/Group Title Eicosapentaenoic Acid (EPA) Docosahexaenoic Acid (DHA) Placebo
Hide Arm/Group Description:

Eicosapentaenoic acid (EPA) Omega-3, 1g/day

eicosapentaenoic acid: 1 gram/day

Docosahexaenoic acid (DHA) Omega-3, 1g/day

docosahexaenoic acid: 1 gram/day

Placebo capsule (980mg soybean oil)

Placebo: 980 milligram/day

Overall Number of Participants Analyzed 60 58 59
Mean (Standard Error)
Unit of Measure: units on a scale
-10.34  (0.62) -9.26  (0.62) -9.49  (0.61)
Time Frame Adverse events were collected over the 8 weeks of the study period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eicosapentaenoic Acid (EPA) Docosahexaenoic Acid (DHA) Placebo
Hide Arm/Group Description

Eicosapentaenoic acid (EPA) Omega-3, 1g/day

eicosapentaenoic acid: 1 gram/day

Docosahexaenoic acid (DHA) Omega-3, 1g/day

docosahexaenoic acid: 1 gram/day

Placebo capsule (980mg soybean oil)

Placebo: 980 milligram/day

All-Cause Mortality
Eicosapentaenoic Acid (EPA) Docosahexaenoic Acid (DHA) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Eicosapentaenoic Acid (EPA) Docosahexaenoic Acid (DHA) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/58 (0.00%)      0/59 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eicosapentaenoic Acid (EPA) Docosahexaenoic Acid (DHA) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/60 (65.00%)      40/58 (68.97%)      43/59 (72.88%)    
Cardiac disorders       
Palpitations   8/60 (13.33%)  8 7/58 (12.07%)  7 2/59 (3.39%)  2
Dizziness on standing   5/60 (8.33%)  5 7/58 (12.07%)  7 4/59 (6.78%)  4
Chest pain   0/60 (0.00%)  0 1/58 (1.72%)  1 1/59 (1.69%)  1
Ear and labyrinth disorders       
Ringing in ears   4/60 (6.67%)  4 2/58 (3.45%)  2 2/59 (3.39%)  2
Eye disorders       
Blurred vision   5/60 (8.33%)  5 5/58 (8.62%)  5 7/59 (11.86%)  7
Gastrointestinal disorders       
Diarrhea   6/60 (10.00%)  6 8/58 (13.79%)  8 11/59 (18.64%)  11
Constipation   8/60 (13.33%)  8 8/58 (13.79%)  8 0/59 (0.00%)  0
Dry mouth   8/60 (13.33%)  8 7/58 (12.07%)  7 4/59 (6.78%)  4
Nausea or vomiting   7/60 (11.67%)  7 8/58 (13.79%)  8 5/59 (8.47%)  5
Nervous system disorders       
Headache   8/60 (13.33%)  8 12/58 (20.69%)  12 12/59 (20.34%)  12
Tremors   1/60 (1.67%)  1 5/58 (8.62%)  5 0/59 (0.00%)  0
Poor coordination   2/60 (3.33%)  2 6/58 (10.34%)  6 4/59 (6.78%)  4
Dizziness   1/60 (1.67%)  1 7/58 (12.07%)  7 4/59 (6.78%)  4
Psychiatric disorders       
Difficulty sleeping   18/60 (30.00%)  18 11/58 (18.97%)  11 12/59 (20.34%)  12
Sleeping too much   4/60 (6.67%)  4 7/58 (12.07%)  7 6/59 (10.17%)  6
Loss of sexual desire   7/60 (11.67%)  7 9/58 (15.52%)  9 12/59 (20.34%)  12
Trouble achieving orgasm   6/60 (10.00%)  6 3/58 (5.17%)  3 2/59 (3.39%)  2
Trouble with erections   1/60 (1.67%)  1 0/58 (0.00%)  0 1/59 (1.69%)  1
Anxiety   10/60 (16.67%)  10 14/58 (24.14%)  14 14/59 (23.73%)  14
Poor concentration   13/60 (21.67%)  13 12/58 (20.69%)  12 14/59 (23.73%)  14
General malaise   5/60 (8.33%)  5 7/58 (12.07%)  7 12/59 (20.34%)  12
Restlessness   4/60 (6.67%)  4 8/58 (13.79%)  8 12/59 (20.34%)  12
Fatigue   14/60 (23.33%)  14 13/58 (22.41%)  13 9/59 (15.25%)  9
Decreased energy   16/60 (26.67%)  16 12/58 (20.69%)  12 13/59 (22.03%)  13
Renal and urinary disorders       
Difficulty urinating   0/60 (0.00%)  0 2/58 (3.45%)  2 0/59 (0.00%)  0
Painful urination   0/60 (0.00%)  0 1/58 (1.72%)  1 0/59 (0.00%)  0
Frequent urination   9/60 (15.00%)  9 5/58 (8.62%)  5 3/59 (5.08%)  3
Reproductive system and breast disorders       
Menstrual irregularity   2/60 (3.33%)  2 3/58 (5.17%)  3 3/59 (5.08%)  3
Skin and subcutaneous tissue disorders       
Rash   2/60 (3.33%)  2 3/58 (5.17%)  3 2/59 (3.39%)  2
Increased perspiration   5/60 (8.33%)  5 5/58 (8.62%)  5 4/59 (6.78%)  4
Itching   4/60 (6.67%)  4 6/58 (10.34%)  6 4/59 (6.78%)  4
Dry skin   6/60 (10.00%)  6 7/58 (12.07%)  7 8/59 (13.56%)  8
Indicates events were collected by systematic assessment
The study was underpowered due to lower than expected recruitment. The high placebo response rate may have impeded signal detection. The n-3 preparations were not pure, but “enriched” for one n-3 or the other, and contained other FAs.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr David Mischoulon, Director of Research, Depression Clinical and Research Program
Organization: Massachusetts General Hospital
Phone: 617-724-5198
Responsible Party: David Mischoulon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00361374     History of Changes
Other Study ID Numbers: 2005P002337
5R01MH074085 ( U.S. NIH Grant/Contract )
First Submitted: August 4, 2006
First Posted: August 8, 2006
Results First Submitted: April 3, 2014
Results First Posted: July 18, 2014
Last Update Posted: July 18, 2014