A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder

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

Research output: Contribution to journalArticle

62 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1636-1644
Number of pages9
JournalJournal of Clinical Psychiatry
Volume70
Issue number12
DOIs
StatePublished - Dec 2009
Externally publishedYes

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Eicosapentaenoic Acid
Major Depressive Disorder
Randomized Controlled Trials
Placebos
eicosapentaenoic acid ethyl ester
Diagnostic and Statistical Manual of Mental Disorders
Gas Chromatography
Depression
Lipids

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

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. Journal of Clinical Psychiatry, 70(12), 1636-1644. https://doi.org/10.4088/JCP.08m04603

A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder. / Mischoulon, David; Papakostas, George I.; Dording, Christina M.; Farabaugh, Amy H.; Sonawalla, Shamsah B.; Agoston, A. Monica; Smith, Juliana; Beaumont, Erin C.; Dahan, Liat E.; Alpert, Jonathan E.; Nierenberg, Andrew A.; Fava, Maurizio.

In: Journal of Clinical Psychiatry, Vol. 70, No. 12, 12.2009, p. 1636-1644.

Research output: Contribution to journalArticle

Mischoulon, D, Papakostas, GI, Dording, CM, Farabaugh, AH, Sonawalla, SB, Agoston, AM, Smith, J, Beaumont, EC, Dahan, LE, Alpert, JE, Nierenberg, AA & Fava, M 2009, 'A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder', Journal of Clinical Psychiatry, vol. 70, no. 12, pp. 1636-1644. https://doi.org/10.4088/JCP.08m04603
Mischoulon D, Papakostas GI, Dording CM, Farabaugh AH, Sonawalla SB, Agoston AM et al. A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder. Journal of Clinical Psychiatry. 2009 Dec;70(12):1636-1644. https://doi.org/10.4088/JCP.08m04603
Mischoulon, David ; Papakostas, George I. ; Dording, Christina M. ; Farabaugh, Amy H. ; Sonawalla, Shamsah B. ; Agoston, A. Monica ; Smith, Juliana ; Beaumont, Erin C. ; Dahan, Liat E. ; Alpert, Jonathan E. ; Nierenberg, Andrew A. ; Fava, Maurizio. / A double-blind, randomized controlled trial of ethyl-eicosapentaenoate for major depressive disorder. In: Journal of Clinical Psychiatry. 2009 ; Vol. 70, No. 12. pp. 1636-1644.
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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.",
author = "David Mischoulon and Papakostas, {George I.} and Dording, {Christina M.} and Farabaugh, {Amy H.} and Sonawalla, {Shamsah B.} and Agoston, {A. Monica} and Juliana Smith and Beaumont, {Erin C.} and Dahan, {Liat E.} and Alpert, {Jonathan E.} and Nierenberg, {Andrew A.} and Maurizio Fava",
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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

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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.

AB - 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.

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