Promising Nutritional Supplements Compared With Placebo
Massachusetts General Hospital (MGH), in collaboration with Cedars-Sinai Medical Center in Los Angeles, is currently undertaking a clinical trial examining the effectiveness of two omega-3 fatty acids - docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) - as treatments for depression.
DHA and EPA are naturally occurring polyunsaturated fatty acids found in fish oils. They are involved in a variety of processes involved in the regulation of mood - including stabilization of brain cell membranes and anti-inflammatory functions. Nutritional supplements containing omega-3 fatty acids have begun to be used to treat a number of psychiatric conditions, and evidence from previous clinical studies suggest they may be effective antidepressants for some people. But no studies have systematically tested DHA and EPA against each other and against placebo in a large sample of people with major depression, as the MGH/Cedars-Sinai trial is doing.
"The omega-3s appear to be a promising treatment for depression," says David Mischoulon, MD, PhD, of the MGH Department of Psychiatry, who is an assistant professor of Psychiatry at Harvard Medical School and one of the principal investigators. "Supplementation with omega-3s may regulate certain brain functions and could reverse a depressed state."
Major depression affects at least 15 percent of the adult population. Unlike normal emotional experiences of sadness, loss, or passing mood states, major depression is persistent and can significantly interfere with an individual's thoughts, behavior and physical health. A leading cause of disability in the U.S. and many other developed countries, major depression can occur at any time of life and can be effectively treated.
The five-year trial is designed to test the safety, effectiveness and tolerability of DHA and EPA compared against each other and a placebo. Participants will receive one of the two drugs or placebo for 8 weeks in a randomized, double-blind manner, which means that neither investigators nor participants will know what treatment an individual receives. At the completion of the study, participants will be eligible for three months of free follow up with one of the study physicians and will be advised on optimal approaches to long-term management of their depression.
The MGH/Cedars-Sinai team will examine the effect of these treatments on the relief of participants' symptoms, their quality of life and psychosocial functioning. They also will examine how fatty acids in the blood and proteins related to immune function are affected by administration of omega-3s. Co-principal investigator Mark Rapaport, MD, chairman of Psychiatry at Cedars- Sinai and professor of Psychiatry at the University of California, Los Angeles, adds, "If the omega-3s prove to be effective, they would be an excellent and safe treatment option for people who have not benefited from regular antidepressants."
The study, which is sponsored by the National Institutes of Health, will recruit a total of 300 adults ages 18 to 80, experiencing significant symptoms of major depressive disorder but in good general health. Participants will receive free and confidential evaluation and treatment as part of the study. No health insurance is required to participate. A comprehensive medical evaluation - including physical examination, laboratory tests, and EKG - may be provided free of charge. Transportation to and from the clinic may also be available.
"The reported side effects of omega-3 treatment have been mild - including upset stomach and a fishy taste in the mouth - and there do not appear to be risks to the liver or adverse interactions with most other medications," Mischoulon explains, although he adds that people with bleeding disorders or who are taking blood thinners should not use omega-3 fatty acids. "This study is just one of several investigations of alternative and complementary medicine that our department has pursued over the past decade. The MGH also has developed several educational programs for professional and lay audiences about the role of natural treatments in psychiatry. Thanks to unrestricted educational grants from various sources, including industry, we've been able to expand our educational offerings to the public."