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Small study shows SAMe may improve
treatment of depression
Adding supplement to antidepressant
medication can help patients with continuing symptoms
BOSTON - November 30, 2004 - Massachusetts General Hospital
(MGH) researchers have found that adding the nutritional supplement
SAMe to a standard antidepressant may be helpful to patients who
have not responded to single-drug treatment for clinical depression.
The pilot study, appearing in the December Journal of Clinical
Psychopharmacology, found that treatment with both SAMe and
an antidepressant improved symptoms in half the study participants
and produced complete relief of symptoms in 43 percent of participants.
"One of the most common problems in treating depression is
the number of people who are left with symptoms after initial treatment
with a first-line antidepressant," says Jonathan Alpert, MD,
associate director of the MGH
Depression Clinical and Research Program, who led the study.
"Some previous trials have suggested that SAMe might have effects
comparable to some antidepressants, but there has not been sufficient
research on oral SAMe preparations or comparisons with available
antidepressants."
A substance that is found in every human cell, SAMe (S-Adenosy-L-Methionine)
is a commonly used dietary supplement. Although some reports had
suggested it might be useful in treating depression, few rigorous
research trials have been carried out. The current study was designed
to investigate whether adding SAMe to antidepressant treatment could
improve the results for patients for whom a single medication had
not relieved symptoms.
The study enrolled 30 participants who had continued to have significant
depression after more than a month of treatment with drugs like
Prozac, Paxil or Effexor. During the six-week study, participants
received SAMe along with their antidepressant, starting at 400 mg
of SAMe two times a day and increasing to 800 mg twice a day after
two weeks. Patients were free to stay at or return to the 400 mg
dose level if they chose to, in consultation with their physician.
At the end of the study period, analysis with several standard tools
for measuring symptoms of depression showed that 50 percent of participants
had significant improvement in their symptoms and 43 percent had
complete remission of their depression. Although two participants
dropped out because of treatment side effects, there were no reports
of serious adverse events.
"This is the first study to look at the safety and efficacy
of combining SAMe with antidepressant treatment after antidepressants
had proven insufficient on their own," says Alpert. "Patients
and physicians have been using these combinations without good supporting
data, and these results are an initial step toward compiling the
necessary scientific evidence."
The MGH team notes that the current study has many limitations -
including its small size, the lack of a control group and the fact
that participants knew they were taking an active dose of SAMe.
The researchers have just begun a National Institutes of Health
(NIH)-sponsored, double-blinded, placebo controlled trial of SAMe
in combination with antidepressant treatment. A second NIH-funded
study will compare SAMe with standard antidepressants and with placebo
as a single-drug therapy. More information on these new studies
is available toll-free at 877 55-BLUES (877 552-5837).
The current study was sponsored by Pharmavite LLC, which manufactures
the Nature Made line of vitamins and nutritional supplements. The
study's co-authors are senior author Maurizio Fava, MD, George Papakostas,
MD, David Mischoulon, MD, PhD, John Worthington, MD, Timothy Petersen,
PhD, Yasmin Mahal, Alana Burns, and Andrew Nierenberg, MD, all of
the MGH Depression and Clinical Research Program; and Teodoro Bottiglieri,
PhD, of Baylor University.
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 more than $400 million
and major research centers in AIDS, cardiovascular research, cancer,
cutaneous biology, medical imaging, neurodegenerative disorders,
transplantation biology and photomedicine. In 1994, MGH and Brigham
and Women's Hospital joined to form Partners HealthCare System,
an integrated health care delivery system comprising the two academic
medical centers, specialty and community hospitals, a network of
physician groups, and nonacute and home health services.
Media Contact: Sue
McGreevey, MGH Public Affairs
Physician Referral Service: 1-800-388-4644
Information about Clinical Trials
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