NCT00517036

Omega-3 Fatty Acids for Treating Adults With Major Depression

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will test the effectiveness of two different kinds of omega-3 fatty acid dietary supplements in treating the symptoms of major depression.

Detailed description

Major depression is a common mental disorder that affects millions of people each year. It can severely impact a person's life, causing someone to often feel sad and hopeless, as well as affect a person's sleep patterns, concentration, and energy levels. Despite the availability of numerous therapies, current treatments are not ideal for some people. Recently, some research has shown that an increase in dietary intake of polyunsaturated fatty acids (PUFAs), such as omega-3 fatty acid, might help treat depression. Eicosapentanoic acid (EPA) and docosahexanoic acid (DHA) are two common types of PUFAs high in omega-3 fatty acids and are available in low dosages in some dietary supplements. The purpose of this study is to compare the effectiveness of an EPA-enriched mixture versus pure DHA versus a placebo in treating the symptoms of major depression. Participants in this double blind study will be randomly assigned to one of three study groups. Participants assigned to the first study group will receive capsules containing 500 mg of an EPA-enriched omega-3 fatty acid preparation. Participants assigned to the second study group will receive capsules containing 500 mg of pure DHA. Participants assigned to the third study group will receive capsules containing a placebo. The study will last approximately 9 weeks. This will include an initial screening the first week followed by an 8-week period during which all participants will take two capsules of their assigned treatment each morning. Participants will attend a total of six study visits. The initial visit will last approximately 2 hours and will include a psychiatric assessment, urine and blood collection, an electrocardiogram (EKG), and a Food Processor Questionnaire. Participants who qualify for further participation will then enter a 1-week washout period during which they will stop taking any current psychotropic medication. At the second study visit, participants will be assigned to their treatment group. Upon starting assigned treatments, participants will then return for study visits every 2 weeks to report any possible side effects and to complete standard psychiatric assessment tests. All of these study visits will take approximately 1 hour, except the last, which will take 2 hours. In addition to the psychiatric assessment and review of side effects, the final study visit will also include a physical exam and blood collection.

Conditions

• Depression

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	EPA omega-3 fatty acid	1 gram per day of an EPA-enriched mixture for 8 weeks
DIETARY_SUPPLEMENT	DHA omega-3 fatty acid	1 gram per day of pure DHA for 8 weeks
DIETARY_SUPPLEMENT	Placebo comparator	1 gram per day of an inactive substance for 8 weeks

Timeline

• Start date: 2006-07-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2007-08-16
• Last updated: 2013-04-04

Locations

1 site across 1 country: United States