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A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder.
J Clin Psychiatry 2009; 70(12):1636-44JC

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.

Authors+Show Affiliations

Massachusetts General Hospital, Depression Clinical and Research Program, Boston, MA 02114, USA. dmischoulon@partners.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

19709502

Citation

Mischoulon, David, et al. "A Double-blind, Randomized Controlled Trial of Ethyl-eicosapentaenoate for Major Depressive Disorder." The Journal of Clinical Psychiatry, vol. 70, no. 12, 2009, pp. 1636-44.
Mischoulon D, Papakostas GI, Dording CM, et al. A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder. J Clin Psychiatry. 2009;70(12):1636-44.
Mischoulon, D., Papakostas, G. I., Dording, C. M., Farabaugh, A. H., Sonawalla, S. B., Agoston, A. M., ... Fava, M. (2009). A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder. The Journal of Clinical Psychiatry, 70(12), pp. 1636-44. doi:10.4088/JCP.08m04603.
Mischoulon D, et al. A Double-blind, Randomized Controlled Trial of Ethyl-eicosapentaenoate for Major Depressive Disorder. J Clin Psychiatry. 2009;70(12):1636-44. PubMed PMID: 19709502.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder. AU - Mischoulon,David, AU - Papakostas,George I, AU - Dording,Christina M, AU - Farabaugh,Amy H, AU - Sonawalla,Shamsah B, AU - Agoston,A Monica, AU - Smith,Juliana, AU - Beaumont,Erin C, AU - Dahan,Liat E, AU - Alpert,Jonathan E, AU - Nierenberg,Andrew A, AU - Fava,Maurizio, Y1 - 2009/08/25/ PY - 2008/08/07/received PY - 2008/11/10/accepted PY - 2009/8/28/entrez PY - 2009/8/28/pubmed PY - 2010/2/24/medline SP - 1636 EP - 44 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 70 IS - 12 N2 - 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. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/19709502/A_double_blind_randomized_controlled_trial_of_ethyl_eicosapentaenoate_for_major_depressive_disorder_ L2 - http://www.psychiatrist.com/jcp/article/pages/2009/v70n12/v70n1203.aspx DB - PRIME DP - Unbound Medicine ER -