studies were restricted to subjects with MDD
(three in mild-moderate MDD, three in moderatesevere
MDD). All 14 studies enrolled only adults;
no placebo-controlled studies of SAM-e in pediatric
patients with depression were identified. Only one
study included an active comparator arm (imipramine).114
Eleven of the 14 studies were conducted
in Europe and three were conducted in the United
States. All 14 studies were short-term, ranging
from 2-6 weeks. No placebo-controlled studies
were identified that assessed the long-term
antidepressant efficacy of SAM-e.
Five of the nine studies in mild-to-moderate
depressives were “positive”, i.e., they reported
statistically significant results favoring SAM-e on
the prospectively defined primary endpoint. Two
other studies in mild-to-moderate depression also
produced numerically favorable results for SAM-e;
however, a statistical comparison between groups
was not provided. !e mean treatment effect size
in the positive studies was 1.0 (range 0.33-1.6), by
convention a large effect size.