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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00093847 |
This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant drug treatment in reducing depressive symptoms in depressed people who have not responded to antidepressants alone.
Condition | Intervention | Phase |
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Depression |
Drug: S-adenosyl methione (SAMe) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | S-Adenosyl Methionine (SAMe) Augmenation of Selective Serotonin Reuptake Inhibitors (SSRIs) for Treatment-Resistant Depression (TRD) |
Estimated Enrollment: | 80 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants receiving the oral SAMe tosylate
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Drug: S-adenosyl methione (SAMe)
Oral SAMe tosylate, up to 1600 mg per day for 6 weeks
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2: Placebo Comparator
Participants receiving placebo
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Drug: Placebo
Placebo to be taken daily for 6 weeks
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Some people with depression do not respond well to antidepressant treatment. S-adenosyl methionine (SAMe) is a naturally occurring compound that may have antidepressant effects. SAMe may also enhance the effectiveness of other antidepressants, such as selective serotonin reuptake inhibitors (SSRIs). This study will determine the effectiveness of oral SAMe in enhancing the effects of SSRIs in patients currently not responding to SSRI treatment.
This study will last 6 weeks. No follow-up visits will occur. Participants will be randomly assigned to add either oral SAMe or placebo to their existing SSRI regimen for 6 weeks. Depression scales and self-report questionnaires regarding depressive symptoms will be used to assess participants at the end of the study.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: George I. Papakostas, MD 617-726-6697 gpapakostas@partners.org | |
Principal Investigator: George I. Papakostas, MD |
Principal Investigator: | George I. Papakostas, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( George I. Papakostas ) |
Study ID Numbers: | K23 MH69629, DATR AK-TNET1 |
Study First Received: | October 6, 2004 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00093847 |
Health Authority: | United States: Federal Government |
Selective Serotonin Reuptake Inhibitors S-adenosyl Methionine SSRI SAMe |
Depression Mental Disorders Mood Disorders |
Depressive Disorder Serotonin Behavioral Symptoms |
Neurotransmitter Agents Serotonin Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Pharmacologic Actions |