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Mass. General, Butler Hospitals testing SAMe for depression treatment
Promising nutritional supplement being compared with SSRI, placebo

BOSTON/PROVIDENCE- June 26, 2007 - Massachusetts General Hospital (MGH), in collaboration with Butler Hospital in Providence, is currently undertaking a clinical trial examining the effectiveness of the nutritional supplement S-adenosyl methionine (SAMe) as a treatment for depression.

A naturally occurring substance found in every human cell, SAMe is known to play a role in the synthesis of serotonin and other brain chemicals involved in the regulation of mood. Nutritional supplements containing SAMe have been used to treat depression, and more than 45 clinical studies have suggested that it may be as effective as the older tricyclic antidepressants for some patients. Current studies, like the MGH/Butler trial, are focused on comparing SAMe with the newer selective serotonin reputake inhibitor (SSRIs) antidepressants.

"SAMe appears to be a promising treatment for depression," says David Mischoulon, MD, PhD, of the MGH Department of Psychiatry, one of the trial's investigators. "It's looking like SAMe supplementation may allow the body to maintain higher levels of critical neurotransmitters that could reverse a depressed state." Mischoulon is an assistant professor of Psychiatry at Harvard Medical School.

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 SAMe compared with the SSRI escitalopram (Lexapro) or a placebo. Participants will initially receive one of the two drugs or placebo for 12 weeks in a randomized, double-blind manner, which means that neither investigators nor participants will know what treatment an individual receives. In the second phase, those whose symptoms did not improve in the first phase will receive a combination of SAMe and escitalopram for another 12 weeks, during which they will be aware of the medication being used. 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-Butler 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 clinical and genetic predictors of antidepressant response and how SAMe treatment may effect or interact with levels of certain proteins in the bloodstream. Lawrence H. Price, M.D., director of research at Butler Hospital and professor of Psychiatry at the Warren Alpert Medical School of Brown University, adds, "This is an important study. If SAMe does prove to be effective, it would be a valuable alternative for people who prefer not to take regular medications."

The study, which is sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health, will recruit adults ages 18 to 65, who are experiencing significant symptoms of major depressive disorder and are 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 SAMe treatment have been mild - including insomnia, loss of appetite, dry mouth, sweating, dizziness, and nervousness - and there do not appear to be risks to liver or adverse interactions with other medications," Mischoulon explains. "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."

Individuals who wish to learn more about the study should call the Massachusetts General Hospital's Depression Clinical and Research Program at (877) 55-BLUES (552-5837) or the Butler Hospital Mood Disorders Research Program at (401) 455-6537.

Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of nearly $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, transplantation biology and photomedicine.


Media Contact: Sue McGreevey, MGH Public Affairs
Jim Hallan, Butler Hospital

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