Journal
JOURNAL OF CLINICAL PSYCHIATRY
Volume 73, Issue 6, Pages 843-848Publisher
PHYSICIANS POSTGRADUATE PRESS
DOI: 10.4088/JCP.11m07139
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Funding
- Amarin (Laxdale)
- Bristol-Myers Squibb
- Cederroth
- Lichtwer Pharma GmbH
- Nordic Naturals
- Ganeden
- Swiss Medica
- Fisher-Wallace
- Abbott
- Alkermes
- Lorex
- Aspect Medical Systems
- AstraZeneca
- Cephalon
- Cyberonics
- Eli Lilly
- Forest
- GlaxoSmithKline
- Johnson Johnson
- Novartis
- Organon Inc
- Pamlab
- Pfizer
- Pharmavite
- Roche
- Sanofi/Synthelabo
- Solvay
- Wyeth-Ayerst
- Belvoir Publishing
- Bio Research
- BrainCells
- Clinical Trial Solutions
- Ganeden Biotech
- National Alliance for Research on Schizophrenia and Depression
- National Center for Complementary and Alternative Medicine
- National Institute on Drug and Alcohol Abuse
- National Institute of Mental Health [5-K23 MH-069629]
- Organon
- Sanofi-Aventis
- Shire
- Synthelabo
- Advanced Meeting Partners
- American Psychiatric Association
- Belvoir
- Boehringer-Ingelheim
- Imedex
- PharmaStar
- Massachusetts General Hospital Psychiatry Academy/Primedia
- Massachusetts General Hospital Psychiatry Academy/Reed-Elsevier
- UBC Pharma
- Ridge Diagnostics
- National Institutes of Health/National Center for Complementary and Alternative Medicine grant [AT002311-01]
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Objective: To characterize the impact of S-adenosyl methionine (SAMe) on homocysteine and potential risk of adverse cardiovascular effects by examining plasma levels of SAMe, S-adenosyl homocysteine (SAH), total homocysteine (tHCY), methionine (MET), and 5-methyltetrahydrofolate (5-MTHF) in 35 of 73 patients from a 6-week randomized double-blind, placebo-controlled trial of SAMe augmentation in serotonin reuptake inhibitor partial responders with DSM-IV major depressive disorder (MDD), published in 2010. Method: Subjects were randomized from June 4, 2004, until August 8, 2008, to adjunctive placebo or SAMe 800-1600 mg/d for 6 weeks. Primary outcome measures included changes in one-carbon cycle intermediates within each treatment arm (by paired t test) and between treatment arms (by independent samples t test). Univariate analysis of variance and Fisher Protected Least Significant Difference were carried out to compare posttreatment levels of each one-carbon cycle intermediate. Secondary outcome measures included associations between clinical improvement and change in plasma intermediate levels, examined by linear regression (for change in Hamilton Depression Rating Scale scores) and logistic regression (for response or remission). Results: We found significant differences in pretreatment plasma levels of tHCY (P = .03) between the SAMe and placebo arms. Following 6 weeks of treatment, plasma SAMe (P = .002) and SAH (P < .0001) levels increased significantly in the SAMe arm; no intermediates in the placebo group changed significantly. Posttreatment plasma SAMe (P = .0035), SAH (P < .0001), and tHCY (P = .0016) levels differed significantly between the SAMe and placebo groups. No significant associations were found between plasma intermediate levels and clinical improvement, response, or remission. Conclusions: Despite concerns about the impact that SAMe therapy may have on homocysteine levels and risk of adverse cardiovascular effects, the lack of significant increase in tHCY levels after treatment suggests that no toxic effects from SAMe should be expected. Our findings, however, have some significant limitations and should be interpreted with caution.
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