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Completed

NCT Number: NCT00361374

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

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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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Depression Clinical Research Program, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eicosapentaenoic acid

Dietary Supplement

1 gram/day

Other names: EPA, Omega-3 Fatty Acid, ProEPAXtra

Docosahexaenoic acid

Dietary Supplement

1 gram/day

Other names: DHA, Omega-3 Fatty Acid, ProDHA

Placebo

Drug

980 milligram/day

Other names: Placebo, Soybean oil

Primary outcomes

  1. Score on a Depression Severity Rating Scale Over Eight Weeks

    Time frame: 8 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Cedars-Sinai Medical Center
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Aug 8, 2006
Registry last updated
Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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