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. Author manuscript; available in PMC: 2017 Dec 1.
Published in final edited form as: J Clin Psychiatry. 2017 Jun;78(6):e656–e667. doi: 10.4088/JCP.16r11113

Table 1.

Controlled Trials of SAMe vs. Placebo for Depression

Trial Year Patients enrolled (randomized) Experimental Design Study duration (days) SAMe dose (mg/day) Route Primary Outcome Measure Primary Outcome (SAMe vs. Placebo) P Value
Total SAMe Placebo Positive Negative
Fazio et al.34 1973 19 14 5 double-blind 8 45 IV HAM-D < 0.01
Agnoli et al.35 1976 30 20 10 double-blind 15 45 IM HAM-D P value for comparison not provided
Barberi et al.36,a 1978 40 20 20 cross-over 10 200 IV HAM-D < 0.05
Muscettola et al.37 1982 20 10 10 double-blind 15 150 IM HAM-D <0.01
Caruso et al.38 1984 49 25 24 double-blind 21 200 IM HAM-D < 0.001
Carney et al.39 1986 32 15 17 double-blind 14 200 IV HAM-D NSb
Caruso et al.40 1987 59 30 29 double-blind 21 200 IM HAM-D < 0.01
De Leo et al.41 1987 40 20 20 double-blind 30 200 IM ZSDS < 0.05
Thomas et al.42 1987 20 9 11 double-blind 14 200 IV HAM-D NSb
Janicak et al.43 1988 15 7 5 double-dummy 15 400 IV HAM-D < 0.02
Carrieri et al.44 1990 21 11 10 cross-over 15 1000 PO HAM-D < 0.05
Kagan et al.45,a 1990 18 9 9 double-blind 21 1600 PO HAM-D < 0.05
Fava et al.46 1992 43 24 31 double-blind 42 1600 PO HAM-D NSc,d,e
Anacarani et al.47 1993 53 41 10 double-blind 21 400f IV IPAT-DS NS g
Salmaggi et al.48,a 1993 80 40 40 double-blind 30 1600 PO HAM-D total < 0.01
Cerutti et al.49,a,h 1993 60 30 30 double-blind 30 1600 PO KSQ NSi
Delle Chiale et al.50 1997 75 40 35 double-blind 21 800 IV MADRS < 0.05
Papakostas et al.51 2010 73 39 34 double-blind/augmentation 45 1600 PO HAM-D % response < 0.05
Mischoulon et al.52 2014 189 64 60 double-blind; escitalopram was third treatment group 84 1600-3200 PO HAM-D total NSc,d
a

SAMe-treated groups only. Significant (p<0.05) improvement by Day 10.

b

SAMe response rate greater than placebo, results not statistically significant

c

SAMe response rate equivalent to placebo

d

Considered failed trials (see text).

e

Describes a post-hoc analysis of TRH as a predictor of response to SAMe in n=32 from a placebo-controlled trial (n=43). Both the larger trial and this subset produced negative results.

f

SAMe does was 400mg IV given every other day at the end of a dialysis session.

g

p value for comparison not present in text, but graphed figure indicates no group difference.

h

Diagnosis was puerperal psychological distress

i

SAMe > placebo at 10 day assessment (p < 0.05), no significant differences at study endpoint.

Abbreviations.

HAM-D, Hamilton Rating Scale for Depression

IPAT-DS, Personality and Ability Testing – Depression Scale

KSQ, Kellner Symptom Questionnaire

NS, not statistically significant

ZSDS, Zung Self-Rating Depression Scale