NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author ManuscriptObjective-We examined the efficacy and tolerability of ethyl-eicosapentaenoate (EPA-E) monotherapy for major depressive disorder (MDD) in a double-blind, randomized controlled pilot study.Methods-57 adults with DSM-IV MDD were randomized from 1/2003-6/2006 to receive 1 gram/day of EPA or placebo (PBO) for 8 weeks. Response criteria were based on the Hamilton-D-17 scale. Subjects' plasma lipid profiles were examined by gas chromatography.Results-35 subjects (63% female; mean age 45+/-13 yrs) were eligible for the intent to treat (ITT) analysis. In the ITT sample, mean HAM-D-17 scores decreased from 21.6+/-2.7 to 13.9+/-8.9 for the EPA group (n=16) and from 20.5+/-3.6 to 17.5+/-7.5 for the PBO group (n=19) (p=0.123); the effect size for EPA was 0.55. ITT response rates were 38% (6/16) for EPA, and 21% (4/19) for PBO (p=0.45). Among the 24 study completers, mean HAM-D-17 scores decreased from 21.3+/-3.0 to 11.1+/-8.1 for the EPA group and from 20.5+/-3.8 to 16.3+/-6.9 for the PBO group (p=0.087); the effect size for EPA was 0.73. Completer response rates were 45% (5/11) for EPA, and 23% (3/13) for PBO (p=0.39). Among EPA subjects, baseline n-6/n-3 ratio was associated with decrease in HAM-D-17 score (r= -0.686, p=0.030) and with treatment response (p=0.032); change in n-6/n-3 ratio was associated with change in HAM-D-17 score (r=0.784, p=0.032). Side effects, reported in 2 EPA subjects and 5 PBO subjects, were exclusively gastrointestinal, mild, and not associated with discontinuation.Conclusions-EPA demonstrated an advantage over placebo that did not reach statistical significance, possibly due to the small sample and low completer rates, which were the major study limitations.

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