This work may not be copied, distributed, displayed, published, reproduced, transmitted, modified, posted, sold, licensed, or used for commercial purposes. By downloading this file, you are agreeing to the publisher’s Terms & Conditions.

Original Articles

A Double-Blind, Randomized Controlled Trial of Ethyl-Eicosapentaenoate for Major Depressive Disorder

David Mischoulon, MD, PhD; George I. Papakostas, MD; Christina M. Dording, MD; Amy H. Farabaugh, PhD; Shamsah B. Sonawalla, MD; A. Monica Agoston, BA; Juliana Smith, BA; Erin C. Beaumont, BA; Liat E. Dahan, BS; Jonathan E. Alpert, MD, PhD; Andrew A. Nierenberg, MD; and Maurizio Fava, MD

Published: August 25, 2009

Article Abstract

Objective: To examine the efficacy and tolerability of ethyl-eicosapentaenoate (EPA-E) monotherapy for major depressive disorder (MDD).

Method: Fifty-seven adults with DSM-IV MDD were randomly assigned from January 2003 until June 2006 to receive 1 g/d of eicosapentaenoic acid (EPA) or placebo for 8 weeks in a double-blind, randomized, controlled pilot study. Response
criteria were on the basis of the 17-item Hamilton Depression Rating Scale (HDRS-17). Subjects’ plasma lipid profiles were examined by gas chromatography.

Results: Thirty-five subjects (63% female; mean’ ‰±’ ‰SD age’ ‰=’ ‰45′ ‰±’ ‰13 years) were eligible for
the intent to treat (ITT) analysis. In the ITT sample, mean’ ‰±’ ‰SD HDRS-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 placebo group (n’ ‰=’ ‰19) (P’ ‰=’ ‰.123); the effect size for EPA was 0.55. ITT response rates were 38% (6/16) for EPA, and 21% (4/19) for placebo (P’ ‰=’ ‰.45). Among the 24 study completers, mean’ ‰±’ ‰SD HDRS-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 placebo group (P’ ‰=’ ‰.087); the effect size for EPA was 0.73. Completer response rates were 45% (5/11) for EPA, and 23% (3/13) for placebo (P’ ‰=’ ‰.39). Among EPA subjects, baseline n-6/n-3 ratio was associated with decrease in HDRS-17 score (r’ ‰=’ ‰−0.686, P’ ‰=’ ‰.030) and with treatment response (P’ ‰=’ ‰.032); change in n-6/n-3 ratio was associated with change in HDRS-17 score (r’ ‰=’ ‰.784, P’ ‰=’ ‰.032). Side effects, reported in 2 EPA subjects and 5 placebo 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.

Trial Registration: clinicaltrials.gov Identifier: NCT00096798

 

Submitted: August 7, 2008; accepted November 10, 2008.

Online ahead of print: August 25, 2009.

Corresponding author: David Mischoulon, PhD, 50 Staniford St, Suite 401, Massachusetts General Hospital, Boston, MA 02114
(dmischoulon@partners.org).

Volume: 70

Quick Links: Depression (MDD)

Continue Reading…

Subscribe to read the entire article

$40.00

Buy this Article as a PDF

References

Sign-up to stay
up-to-date today!

SUBSCRIBE

Already registered? Sign In

Original Research

Young-Adult Social Outcomes of Attention-Deficit/Hyperactivity Disorder

ADHD that persisted into young-adulthood was associated with poorer outcomes in terms of education, employment, and emotional...

Read More...