BOSTON (August 31, 2010) — A new study conducted by investigators at Harvard Medical School and Massachusetts General Hospital (MGH) suggests that S-Adenosyl Methionine (SAMe), an over-the-counter dietary supplement, can be an effective, relatively well-tolerated, adjunctive treatment for adults with major depressive disorders who do not respond to their treatment with antidepressant medication. This first-of-its-kind study was published in the August 2010 American Journal of Psychiatry. According to the National Institute of Mental Health, there are approximately 14.8 million people with major depressive disorders in the United States.
The study, "S-Adenosyl Methionine (SAMe) Augmentation of Serotonin Reuptake Inhibitors for Antidepressant Nonresponders With Major Depressive Disorder: A Double-Blind, Randomized Clinical Trial," is the first randomized, placebo-controlled clinical trial conducted on SAMe in a population of patients with major depressive disorders. A total of 73 adults were enrolled in this six week study and randomly assigned to the placebo control group or the SAMe treatment group. SAMe, in combination with standard depression treatment, was more effective than antidepressant treatment alone in improving measures of depression and remission rates of patients with significant clinical depression. SAMe-treated subjects had a greater response and remission rate to treatment than the placebo-treated group. SAMe was well-tolerated with no reported adverse reactions.
"With each study we continue to gain a better understanding of SAMe's role in treating depression. This new finding, albeit preliminary and in urgent need of replication, suggests significant, clinically meaningful differences in outcome among patients who had SAMe added to their antidepressant medication treatment compared to those taking a placebo with their medication," said George Papakostas, M.D., associate professor of psychiatry at Harvard Medical School, director of treatment-resistant depression studies in the Department of Psychiatry at MGH, lead author of the current study. "These findings provide preliminary support for the efficacy, safety, and tolerability of SAMe as an additive therapy for patients with major depressive disorders who do not respond to antidepressant treatment alone. Continued research, however, is urgently needed to more definitively further our understanding of the role of SAMe in the treatment of adults diagnosed with depression. Adjunctive SAMe therapy is promising, but cannot yet be recommended for wide-spread clinical use," said Papakostas.
The National Institute of Mental Health funded the study. Pharmavite LLC, the manufacturer of Nature Made SAM-e Complete and the leading distributor of SAMe supplements in the United States, provided the SAMe supplements and placebo pills used in the study.
To date, at least 40 clinical trials have been conducted on SAMe directly and in combination with traditional antidepressant medications. Studies have evaluated SAMe's use in naturally restoring a healthy mood to the most recent research for treating major depressive disorders. This current study follows a pilot study published in 2004 in the Journal of Clinical Psychopharmacology, which concluded that antidepressants used in combination with SAMe were significantly more effective in relieving depression than medication alone.
In an accompanying editorial, J. Craig Nelson, M.D., professor of psychiatry at the University California, San Francisco, wrote, "The study of Papakostas, et al. is persuasive. It is the first adjunctive treatment trial of SAMe and the first placebo-controlled trial of oral SAMe since 1993. The era of development for new amine reuptake inhibitors appears to be coming to a close. Some novel approaches appear to be dead ends. SAMe offers a novel mechanism of treatment action and opens up a new area for future exploration. Of course this clinical trial requires replication. And there are numerous other questions about long-term safety and efficacy, comparisons with other adjunctive agents, and selection of appropriate patients. But demonstration of a new treatment for depression with a novel mechanism is exciting news."
Nature Made, the number one supplement brand in the food, drug, club and mass channels, has been and continues to be an industry leader, frequently supporting third-party research in order to advance the supplement industry as a whole. To date, Nature Made products have been used in more than 100 clinical studies, which serves as a strong testament to the brand's quality, safety and efficacy.
Anyone with depression should first consult your doctor before taking any product containing SAMe. For more information about SAM-e Complete, consumers can visit www.NatureMade.com or call toll-free at 1-800-276-2878.
About Pharmavite LLC
For almost 40 years, Pharmavite LLC has earned and maintained the trust of healthcare professionals, consumers, and retailers by manufacturing high-quality vitamins, minerals, herbs and other dietary supplements that are safe, effective and science-based. Nature Made vitamins is the number one selling brand in the food, drug, club and mass channels. The dietary supplement industry is regulated by the U.S. Food and Drug Administration and the Federal Trade Commission, as well as by government agencies in each of the 50 states.
Additional Information for the Media:
Study Title: S-Adenosyl Methionine (SAMe) Augmentation of Serotonin Reuptake Inhibitors for Antidepressant Nonresponders With Major Depressive Disorder: A Double-Blind, Randomized Clinical Trial
Journal: First appeared online July 1, 2010 and published in the August 2010 issue, Am J Psychiatry 2010; 167:942-948.
Authors: George I. Papakostas, M.D., David Mischoulon, M.D., Ph.D., Irene Shyu, B.A., Jonathan E. Alpert, M.D., Ph.D., Maurizio Fava, M.D. (Mass General Hospital; Harvard University Medical School)
Study Objective: Investigate the use of S-ade¬nosyl methionine (SAMe), a naturally oc¬curring molecule that serves as a methyl donor in human cellular metabolism, as adjunctive treatment for antidepressant nonresponders with major depressive dis¬order.
Study Method: Participants were 73 adult serotonin reuptake inhibitor (SRI) nonresponders with major depressive disorder enrolled in a 6-week, double-blind, randomized trial of adjunctive oral SAMe (target dose: 800 mg/twice daily). Patients continued to receive their SRI treatment at a stable dose throughout the 6-week trial. The pri¬mary outcome measure for the study was the response rates according to the 17- item Hamilton Depression Rating Scale (HAM–D).
Results: The HAM–D response and re¬mission rates were higher for patients treated with adjunctive SAMe (36.1% and 25.8%, respectively) than adjunctive pla¬cebo (17.6% versus 11.7%, respectively). The number needed to treat for response and remission was approximately one in six and one in seven, respectively. There was no statistically significant difference in the proportion of SAMe- versus place¬bo-treated patients who discontinued the trial for any reason (20.6% versus 29.5%, respectively), due to adverse events (5.1% versus 8.8%, respectively), or due to inef¬ficacy (5.1% versus 11.7%, respectively).
Conclusions: These preliminary results suggest that SAMe can be an effective, well-tolerated, and safe adjunctive treat¬ment strategy for SRI nonresponders with major depressive disorder and warrant replication.
Journal
American Journal of Psychiatry