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

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Dietary Supplement: eicosapentaenoic acid; Dietary Supplement: docosahexaenoic acid; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00361374

2005P002337

5R01MH074085 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 196 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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196 participants in 3 patient groups, including a placebo group

EPA

Experimental group

Description:

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

Treatment:

Dietary Supplement: eicosapentaenoic acid

DHA

Experimental group

Description:

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

Treatment:

Dietary Supplement: docosahexaenoic acid

Placebo

Placebo Comparator group

Description:

Placebo capsule (980mg soybean oil)

Treatment:

Drug: Placebo