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Mass. General Hospital, Cedars-Sinai
Medical Center testing Omega-3s for depression treatment
Promising nutritional supplements
being compared with placebo
BOSTON - October 22, 2007 - 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.”
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 Cedars-Sinai at 888-CEDARS-3.
Founded in 1811, the MGH is the third oldest general hospital in
the United States and the oldest and largest in New England. The
900-bed medical center offers sophisticated diagnostic and therapeutic
care in virtually every specialty and subspecialty of medicine and
surgery. Each year the MGH admits more than 46,000 inpatients and
handles nearly 1.5 million outpatient visits at its main campus
and health centers. Its Emergency Department records nearly 80,000
visits annually. The surgical staff performs more than 35,000 operations
and the MGH Vincent Obstetrics Service delivers more than 3,500
babies each year. The MGH conducts the largest hospital-based research
program in the country, with an annual research budget of more than
$500 million. It is the oldest and largest teaching hospital of
Harvard Medical School, where nearly all MGH staff physicians serve
on the faculty. The MGH is consistently ranked among the nation’s
top hospitals by US News and World Report.
Media Contacts: Valerie
Wencis, MGH Public Affairs
Simi Singer, Cedars-Sinai
Medical Center
Physician Referral Service: 1-800-388-4644
Information about Clinical Trials
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