Ethyl-eicosapentaenoic Acid for the Treatment of Psychological Distress and Depressive Symptoms in Middle-Aged Women: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial

Am J Clin Nutr. 2009 Feb;89(2):641-51. doi: 10.3945/ajcn.2008.26749. Epub 2008 Dec 30.

Abstract

Background: Psychological distress (PD) and depressive symptoms are commonly observed during menopausal transition. Studies suggest that omega-3 (n-3) fatty acids may help alleviate depression.

Objective: The objective was to compare enriched ethyl-eicosapentaenoic acid (E-EPA) supplementation with placebo for the treatment of PD and depressive symptoms in middle-aged women.

Design: Women with moderate-to-severe PD (n = 120) were randomly assigned to receive 1.05 g E-EPA/d plus 0.15 g ethyl-docosahexaenoic acid/d (n = 59) or placebo (n = 61) for 8 wk. The main outcomes were 8-wk changes in PD scores [Psychological General Well-Being Schedule (PGWB)] and depressive scales [20-item Hopkins Symptom Checklist Depression Scale (HSCL-D-20) and the 21-item Hamilton Depression Rating Scale (HAM-D-21)].

Results: At baseline, women with PD were mildly to moderately depressed, and 24% met the major depressive episode (MDE) criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition. After 8 wk, outcomes improved in both groups, but no significant differences were noted between them. Stratification analyses for MDE diagnosis at baseline indicated that differences in adjusted 8-wk changes between the E-EPA group without MDE (n = 46) and the placebo group (n = 45) were 8.0 (95% CI: 0.6, 15.3; P = 0.034) for the PGWB, -0.2 (95% CI: -0.01, -0.4; P = 0.040) for the HSCL-D-20, and -2.7 (95% CI: -0.3, -5.1; P = 0.030) for the HAM-D-21. Differences in adjusted 8-wk changes between the E-EPA group with MDE (n = 13) and the placebo group (n = 16) were not significant.

Conclusions: To our knowledge, this is the first trial of n-3 supplementation in the treatment of PD and depressive symptoms in middle-aged women. In women with PD without MDE at baseline, the 8-wk changes in PD and depressive scales improved significantly more with E-EPA than with placebo. This trial was registered at http://www.controlled-trials.com as ISRCTN69617477.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antidepressive Agents / therapeutic use*
  • Depression / drug therapy*
  • Dietary Supplements
  • Double-Blind Method
  • Eicosapentaenoic Acid / analogs & derivatives*
  • Eicosapentaenoic Acid / therapeutic use
  • Female
  • Humans
  • Mental Health*
  • Mental Status Schedule
  • Middle Aged
  • Placebos
  • Psychiatric Status Rating Scales
  • Severity of Illness Index
  • Stress, Psychological / drug therapy*
  • Treatment Outcome

Substances

  • Antidepressive Agents
  • Placebos
  • eicosapentaenoic acid ethyl ester
  • Eicosapentaenoic Acid

Associated data

  • ISRCTN/ISRCTN69617477