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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Dietary Supplement: eicosapentaenoic acid
* Dietary Supplement: docosahexaenoic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged 18-80 years old. Must meet criteria for current Major Depressive Disorder. Exclusion Criteria: Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease History of seizure disorder. Substance use disorders, including alcohol, active within the last six months (past history is OK). History of multiple adverse drug reactions or allergy to the study drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPA<br>Eicosapentaenoic acid (EPA) Omega-3, 1g/day | Dietary Supplement: eicosapentaenoic acid<br>* 1 gram/day<br>* Other names: EPA, Omega-3 Fatty Acid, ProEPAXtra;|
| Experimental: DHA<br>Docosahexaenoic acid (DHA) Omega-3, 1g/day | Dietary Supplement: docosahexaenoic acid<br>* 1 gram/day<br>* Other names: DHA, Omega-3 Fatty Acid, ProDHA;|
| Placebo Comparator: Placebo<br>Placebo capsule (980mg soybean oil) | Drug: Placebo<br>* 980 milligram/day<br>* Other names: Placebo, Soybean oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Omega-3, Boston