Ethyl-eicosapentaenoic acid for the treatment of psychological distress and depressive symptoms in middle-aged women: a double-blind, placebo-controlled, randomized clinical trial.
What this study found
E-EPA did not show a significant overall benefit over placebo for psychological distress or depressive symptoms in the full sample. Adjusted 8-wk between-group differences were not significant for PGWB, 3.3 (95% CI: -2.9, 9.6; P = 0.2908), HSCL-D-20, -0.08 (95% CI: -0.27, 0.12; P = 0.4311), or HAM-D-21, -1.5 (95% CI: -3.7, 0.7; P = 0.1686). In women without major depressive episode at baseline (n = 91), E-EPA was associated with greater improvement on PGWB, 8.0 (95% CI: 0.6, 15.3; P = 0.034), HSCL-D-20, -0.2 (95% CI: -0.4, -0.01; P = 0.040), and HAM-D-21, -2.7 (95% CI: -5.1, -0.3; P =…
- Study & population
- Double-blind, placebo-controlled randomized clinical trial conducted in Canada in women aged 40 to 55 years with moderate-to-severe psychological distress during the menopausal transition.
- Intervention
- Participants received oral ethyl-eicosapentaenoic acid (E-EPA) capsules, 3 daily for 8 wk, for a total daily dose of 1.05 g EPA and 0.15 g DHA.
- Key limitation
- The intervention was short term (8 wk) and the active arm was relatively small, limiting power for the primary analysis and especially for subgroup comparisons.
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Open PDFOriginal 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.