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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01MH074085 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Cedars-Sinai Medical Center | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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This study examines the difference in the effectiveness of two natural compounds, eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is believed that a deficiency in these omega-3 fatty acids may lead to the development of major depression.
The study lasts for eight weeks and involves four visits after the screen and baseline visits (biweekly). Participants will be randomized, or chosen by chance, to enter into one of three groups. People in the first group will take 1 g/day or EPA omega-3 fatty acid, those in the second group will take 1 g/day of DHA omega-3 fatty acid, and those in the third group will take a placebo. This study is double-blind, which means that neither the participant, nor the doctor, nor the research staff will know which group each person is in. At the end of the study the participant will be offered three months of follow-up care at the Depression Clinical and Research Program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPA | Experimental | Eicosapentaenoic acid (EPA) Omega-3, 1g/day |
|
| DHA | Experimental | Docosahexaenoic acid (DHA) Omega-3, 1g/day |
|
| Placebo | Placebo Comparator | Placebo capsule (980mg soybean oil) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eicosapentaenoic acid | Dietary Supplement | 1 gram/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Score on a Depression Severity Rating Scale Over Eight Weeks | 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Mischoulon, MD, PhD | Depression Clinical and Research Program, Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Depression Clinical Research Program, Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34817851 | Derived | Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5. |
| Label | URL |
|---|---|
| The Depression Clinical and Research Program at Massachusetts General Hospital | View source |
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196 adults with MDD were recruited from 05/18/06 to 06/30/11 at Massachusetts General Hospital and Cedars-Sinai Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Eicosapentaenoic Acid (EPA) | Eicosapentaenoic acid (EPA) Omega-3, 1g/day eicosapentaenoic acid: 1 gram/day |
| FG001 | Docosahexaenoic Acid (DHA) | Docosahexaenoic acid (DHA) Omega-3, 1g/day docosahexaenoic acid: 1 gram/day |
| FG002 | Placebo | Placebo capsule (980mg soybean oil) Placebo: 980 milligram/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Eicosapentaenoic Acid (EPA) | Eicosapentaenoic acid (EPA) Omega-3, 1g/day eicosapentaenoic acid: 1 gram/day |
| BG001 | Docosahexaenoic Acid (DHA) | Docosahexaenoic acid (DHA) Omega-3, 1g/day docosahexaenoic acid: 1 gram/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Score on a Depression Severity Rating Scale Over Eight Weeks | 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. | We randomized 196 of 389 screened patients. Nineteen subjects dropped out before completing at least one post-baseline visit, leaving 177 evaluable subjects | Posted | Mean | Standard Error | units on a scale | 8 weeks |
Adverse events were collected over the 8 weeks of the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eicosapentaenoic Acid (EPA) | Eicosapentaenoic acid (EPA) Omega-3, 1g/day eicosapentaenoic acid: 1 gram/day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr David Mischoulon, Director of Research, Depression Clinical and Research Program | Massachusetts General Hospital | 617-724-5198 | dmischoulon@partners.org |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| D015525 | Fatty Acids, Omega-3 |
| D004281 | Docosahexaenoic Acids |
| D013024 | Soybean Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| docosahexaenoic acid | Dietary Supplement | 1 gram/day |
|
|
| Placebo | Drug | 980 milligram/day |
|
|
| BG002 | Placebo | Placebo capsule (980mg soybean oil) Placebo: 980 milligram/day |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Eicosapentaenoic Acid (EPA) | Eicosapentaenoic acid (EPA) Omega-3, 1g/day eicosapentaenoic acid: 1 gram/day |
| OG001 | Docosahexaenoic Acid (DHA) | Docosahexaenoic acid (DHA) Omega-3, 1g/day docosahexaenoic acid: 1 gram/day |
| OG002 | Placebo | Placebo capsule (980mg soybean oil) Placebo: 980 milligram/day |
|
|
| 0 |
| 60 |
| 39 |
| 60 |
| EG001 | Docosahexaenoic Acid (DHA) | Docosahexaenoic acid (DHA) Omega-3, 1g/day docosahexaenoic acid: 1 gram/day | 0 | 58 | 40 | 58 |
| EG002 | Placebo | Placebo capsule (980mg soybean oil) Placebo: 980 milligram/day | 0 | 59 | 43 | 59 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea or vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Dizziness on standing | Cardiac disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Increased perspiration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Tremors | Nervous system disorders | Systematic Assessment |
|
| Poor coordination | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Blurred vision | Eye disorders | Systematic Assessment |
|
| Ringing in ears | Ear and labyrinth disorders | Systematic Assessment |
|
| Difficulty urinating | Renal and urinary disorders | Systematic Assessment |
|
| Painful urination | Renal and urinary disorders | Systematic Assessment |
|
| Frequent urination | Renal and urinary disorders | Systematic Assessment |
|
| Menstrual irregularity | Reproductive system and breast disorders | Systematic Assessment |
|
| Difficulty sleeping | Psychiatric disorders | Systematic Assessment |
|
| Sleeping too much | Psychiatric disorders | Systematic Assessment |
|
| Loss of sexual desire | Psychiatric disorders | Systematic Assessment |
|
| Trouble achieving orgasm | Psychiatric disorders | Systematic Assessment |
|
| Trouble with erections | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Poor concentration | Psychiatric disorders | Systematic Assessment |
|
| General malaise | Psychiatric disorders | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | Systematic Assessment |
|
| Fatigue | Psychiatric disorders | Systematic Assessment |
|
| Decreased energy | Psychiatric disorders | Systematic Assessment |
|
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| D001519 |
| Behavior |
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |