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Omega-3 fatty acids for major depressive disorder associated with the menopausal transition: a preliminary open trial

Freeman, Marlene P. MD1; Hibbeln, Joseph R. MD2; Silver, Michael MS3; Hirschberg, April M. MD3; Wang, Betty MD1; Yule, Amy M. MD1; Petrillo, Laura F. MD1; Pascuillo, Erica BS3; Economou, Nicole I. BS3; Joffe, Hadine MD, MSc1*; Cohen, Lee S. MD1*

doi: 10.1097/gme.0b013e3181f2ea2e
Original Articles
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Objectives: We sought to obtain preliminary data regarding the efficacy of omega-3 fatty acids for major depressive disorder associated with the menopausal transition. Secondary outcomes were assessed for vasomotor symptoms (or hot flashes).

Methods: After a single-blind placebo lead-in, participants received 8 weeks of treatment with open-label omega-3 fatty acid capsules (eicosapentaenoic acid and docosahexaenoic acid, 2 g/d). The Montgomery-Asberg Depression Rating Scale (MADRS) was the primary outcome measure. Hot flashes were monitored prospectively using daily diaries and the Hot Flash Related Daily Interference Scale. Blood samples for plasma pretreatment and posttreatment essential fatty acid assays were obtained. Because of the small sample size, data were analyzed using nonparametric techniques.

Results: Of 20 participants treated with omega-3 fatty acids, 19 (95%) completed the study. None discontinued because of adverse effects. The pretreatment and final mean MADRS scores were 24.2 and 10.7, respectively, reflecting a significant decrease in MADRS scores (P < 0.0001). The response rate was 70% (MADRS score decrease of ≥50%), and the remission rate was 45% (final MADRS score of ≤7). Responders had significantly lower pretreatment docosahexaenoic acid levels than nonresponders did (P = 0.03). Hot flashes were present in 15 (75%) participants. Among those with hot flashes at baseline, the number of hot flashes per day improved significantly from baseline (P = 0.02) and Hot Flash Related Daily Interference Scale scores decreased significantly (P = 0.006).

Conclusions: These data support further study of omega-3 fatty acids for major depressive disorder and hot flashes in women during the menopausal transition.

From the 1Massachusetts General Hospital, Harvard Medical School, Boston, MA; 2National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD; and 3Department of Psychiatry, Massachusetts General Hospital, Boston, MA.

Received April 29, 2010; revised and accepted July 12, 2010.

*Shared last author.

Funding/support: This study was funded by an investigator-initiated grant from GlaxoSmithKline (GSK). GSK had no input on the study implementation, data analysis, or manuscript preparation. This work was completed at Massachusetts General Hospital.

Financial disclosure/conflicts of interest: Marlene P. Freeman, MD-research support from investigator-initiated trials: Forest, GSK, and Lilly. CME support of program: Pam Lab. Stipend for medical editing: DSM Nutritionals. Speaking: none. Consulting: none. Stock: none. Hadine Joffe, MD, MSc-research support to the Perinatal and Reproductive Psychiatry Program: Bayer HealthCare Pharmaceuticals, Forest Laboratories, Inc., and GSK. Speaking/honoraria: none. Advisory/consulting: Sanofi-Aventis and Pfizer. Royalty/patent, other income: None. Lee S. Cohen, MD-research support: Astra-Zeneca Pharmaceuticals, Bayer HealthCare Pharmaceuticals,Bristol-Myers Squibb, Forest Laboratories, Inc., GSK, National Institute on Aging, National Institutes of Health, National Institute of Mental Health, Ortho-McNeil Janssen, and Pfizer Inc. Advisory/consulting: Eli Lilly & Company and Noven. Honoraria: none. Royalty/patent, other income: None.Michael Silver, Joseph Hibbeln, Amy Yule, April Hirschberg, Betty Wang, Laura Petrillo, Erica Pascuillo, Nicole Economou-nothing to disclose.

Address correspondence to: Marlene P. Freeman, MD, Massachusetts General Hospital, Perinatal and Reproductive Psychiatry Program, 185 Cambridge Street, Boston, MA 02114. E-mail: mfreeman@partners.org

©2011The North American Menopause Society