According to the Substance Abuse and Mental Health Services Administration’s latest National Survey on Drug Use and Health (Nov. 15, 2005), depression is one of the leading causes of disability in the U.S. In 2004, 8% of adults aged 18 or older—an estimated 17 million adults—reported having experienced at least one major depressive episode (MDE) during the year. Among adults aged 18 or older who experienced at least one MDE during the past year, 65% reported having received treatment for depression during the year.
While there are many pharmaceutical treatments for depression, researchers at Cedars-Sinai Medical Center’s Department of Psychiatry and Behavioral Neurosciences in Los Angeles, CA, are two years into a five-year clinical trial designed to examine whether two polyunsaturated omega 3 fatty acids—docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)—might be effective treatments for depression. DHA and EPA, found naturally in fish oil, flaxseed and walnuts, have anti-inflammatory properties and help stabilize brain cell membranes, both of which play a role in mood regulation. While previous studies have documented omega 3 fatty acids to be effective treatments for depression, this is the first study to systematically test these two specific fatty acids against each other and against placebo in a large sample of people with major depression.
Mark Hyman Rapaport, MD, the research team’s lead principal investigator and department chair, explained that there is a real need to develop new and safer treatments for Major Depression (MDD). “One area of interest is the role of n-3 fatty acids (alpha linolenic acid, or ALA, and EPA and DHA) as an intervention in MDD because of the confluence of several lines of data—data suggesting that some people with MDD have increased levels of the same pro-inflammatory cytokines increased in heart disease; the symptom of depression is a risk factor for the development of cardiovascular disease; and increasing n-3 fatty acids has been shown to decrease production of pro-inflammatory cytokines and reduce the risk of heart disease,” he said.
The National Institutes of Health (NIH)-sponsored study, held in collaboration with Massachusetts General Hospital, is in the midst of recruiting 300 adults, aged 18-80, who are experiencing significant symptoms of major depressive disorder and are in good health. “Major Depression” consists of two weeks or more of feeling sad/blue most of the day, loss of interest in usual activities/or pleasurable activities, feeling helpless/hopeless, problems with concentration, sleep, appetite, irritability, anxiety, suicidal thoughts and dysfunction at work or socially. Ideal participants are those afflicted by one of the first two symptoms and four of the other symptoms, plus dysfunction. They will also be medication-free so researchers can study the effect of the omega 3 fatty acids from a monotherapy perspective, as well as determine the safety, effectiveness and tolerability of DHA and EPA against each other and a placebo. Participants will receive 1 gram per day of one of the two drugs or a placebo for 8 weeks in a randomized, double-blind manner.
“We want to discern if n-3 fatty acids represent a reasonable treatment approach for some people with MDD,” said. Dr. Rapaport. “Our study will be large enough to discern if EPA or DHA is effective versus placebo, and if there is a relationship between the n-3 fatty acids and changes in pro-inflammatory cytokines and n-3 ratios in red blood cell membranes.”
OmegaBrite is the omega 3 supplement that will be used in this study. It comes from Omega Natural Science, Inc., Waltham, MA. OmegaBrite, as described by the company’s Carol Locke, MD, president and founder, is a “super high 90% concentrate of pure omega 3…the first high EPA omega 3 with 70% pure EPA and creating the first pharmaceutical grade omega 3 supplement.”
“The reported side effects of omega 3 treatments have been mild and include upset stomach and a fishy taste in the mouth. There do not appear to be risks to the liver or adverse interactions with most other medications,” reported Dr. Rapaport, though he added that people who have bleeding disorders or who are taking blood thinners should not use omega 3 fatty acids. “This study is one of several investigations of alternative and complementary medicine that our department has pursued over the past decade. Expanding our psychiatry studies to include natural treatments has shown promising benefits to patients suffering from a variety of mental illnesses.”