Ethyl-eicosapentaenoic acid for the treatment of psychological distress and depressive symptoms in middle-aged women: a double-blind, placebo-controlled, randomized clinical trial

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.comas ISRCTN69617477.