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

¹ From the Lucie and André Chagnon Chair for the Teaching of an Integrated Approach in Prevention, Laval University, Saint-François d'Assise Hospital (CHUQ), Quebec, Canada (ML, GA, and SD); the Department of Psychiatry, Robert Giffard Research Centre, Laval University, Quebec, Canada (CM and M-JP); and the Department of Obstetrics and Gynaecology, Laval University, Quebec, Canada (SD).

² Supported by the Lucie and André Chagnon Chair for the Teaching of an Integrated Approach in Prevention, Laval University. Omega-3 capsules and matching placebo for the study were provided by Isodis Natura (Brussels, Belgium).

³ Reprints not available. Address correspondence to M Lucas, Lucie and André Chagnon Chair for the Teaching of an Integrated Approach in Prevention, Laval University, Saint-François d'Assise Hospital (CHUQ), 45 Leclerc Street, Room D6-701, Quebec, Canada G1L 2G1. E-mail: michel.lucas{at}crchul.ulaval.ca.

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.