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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2013-03-31

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.

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EPA

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

Group Type EXPERIMENTAL

eicosapentaenoic acid

Intervention Type DIETARY_SUPPLEMENT

1 gram/day

DHA

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

Group Type EXPERIMENTAL

docosahexaenoic acid

Intervention Type DIETARY_SUPPLEMENT

1 gram/day

Placebo

Placebo capsule (980mg soybean oil)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

980 milligram/day

Interventions

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eicosapentaenoic acid

1 gram/day

Intervention Type DIETARY_SUPPLEMENT

docosahexaenoic acid

1 gram/day

Intervention Type DIETARY_SUPPLEMENT

Placebo

980 milligram/day

Intervention Type DRUG

Other Intervention Names

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EPA, Omega-3 Fatty Acid, ProEPAXtra DHA, Omega-3 Fatty Acid, ProDHA Placebo, Soybean oil

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No