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Therapeutic Areas: Psychiatry/Psychology
Disease Category: Depression (Major/Severe)

Trial Information

A Double-Blind, Placebo-Controlled Study of the Alternative Therapy S-Adenosyl-L-Methionine (SAMe) vs. Escitalopram (Lexapro) in Major Depressive Disorder.

A Double-Blind, Placebo-Controlled Study of the Alternative Therapy S-Adenosyl-L-Methionine (SAMe) vs. Escitalopram (Lexapro) in Major Depressive Disorder.

Adults between the ages of 18-80 years old who are currently displaying symptoms of depression (feeling sad, losing interest in previously enjoyable activities, changes in sleep and appetite) are asked to participate in a 24-week research study to determine the effectiveness of a substance called SAMe. SAMe is naturally produced by the body. It is also sold as an over-the-counter dietary supplement to improve mood and emotional well-being. Because it is a dietary supplement, SAMe has not yet been approved by the FDA for treatment of depression, but it is possible that SAMe may have antidepressant benefits. In this study, SAMe is being compared to Escitalopram (Lexapro), a currently approved medical therapy, and placebo (contains no active ingredients).

After having a complete psychiatric evaluation, eligible participants will have weekly visits for three weeks and biweekly visits for the remainder of the study. Participants will receive either SAMe, Lexapro, or placebo. At the end of 12 weeks, participants who are not responding or only partially responding to treatment will receive a combination of open-label (no chance of receiving placebo) Lexapro and SAMe for the remainder of the study. Participants receive medications and study visits at no cost as well as $25 for each visit they complete.

For more information, please contact the Depression Clinical and Research program at
1-877-55-BLUES.

Protocol#2004P001153

Rachel Larocca, CRC
Massachusetts General Hospital
55 Fruit Street
Boston, MA 02114
Phone: 617-724-3673
EMail: ralarocca@partners.org

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Research Center Information: Massachusetts General Hospital

If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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