Studies that enrolled subjects representing all
levels of MDD symptom severity were included in
the review. If the depression severity level was not
stated (i.e., mild, moderate, severe), then depression
severity was based on any identified HAM-D
(or other suitable scale) cutoff criteria for entry. In
the absence of that, the actual mean HAM-D total
score at entry was used (e.g., 17-item HAM-D total
scores of ≤ 16 were classified as mild, 17-24 as
moderate, and > 24 as severe).72 !e studies could
involve acute (short-term) or long-term dosing. If
long-term, in order to have been included, the
study must have utilized a re-randomization
relapse-prevention design, as opposed to simply
continuing subjects on the same acute study
treatment for an extended length of time.
SJW and SAM-e as monotherapies have also
been evaluated in placebo-controlled trials in
psychiatric disorders other than depression. !ese
studies were not utilized for the systematic review
of efficacy in depression; however, they were
considered appropriate for the safety-related
review. Placebo-controlled studies in disorders
other than depression that evaluated SJW or
SAM-e as adjunctive treatment or in combination
with another alternative product were not included
in either the efficacy or safety reviews.