SAMe was not different from placebo and established antidepressants .
The exception was that compared to imipramine , fewer participants experienced troublesome adverse effects when treated with parenteral SAMe .
BACKGROUND Depression is a recurrent illness with high rates of chronicity , treatment-resistance and significant economic impact .
There is evidence in the literature that S-adenosyl methionine ( SAMe ) , a naturally occurring compound in the human body , has antidepressant efficacy .
This product may be an important addition to the armamentarium of antidepressant agents .
OBJECTIVES To assess the effects of SAMe in comparison with placebo or antidepressants for the treatment of depression in adults .
Bioavailability of S-adenosyl methionine and impact on response in a randomized, double-blind, placebo-controlled trial in major depressive disorder.
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 r and omized 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 r and omized 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 sample s 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 . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00093847
SAMe was not different from placebo and established antidepressants .
The exception was that compared to imipramine , fewer participants experienced troublesome adverse effects when treated with parenteral SAMe .
BACKGROUND Depression is a recurrent illness with high rates of chronicity , treatment-resistance and significant economic impact .
There is evidence in the literature that S-adenosyl methionine ( SAMe ) , a naturally occurring compound in the human body , has antidepressant efficacy .
This product may be an important addition to the armamentarium of antidepressant agents .
OBJECTIVES To assess the effects of SAMe in comparison with placebo or antidepressants for the treatment of depression in adults .