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Treatment of Depression and Menopause-Related Symptoms With the Serotonin-Norepinephrine Reuptake Inhibitor Duloxetine
Hadine Joffe, M.D., M.Sc.; Claudio N. Soares, M.D., Ph.D.; Laura F. Petrillo, M.D.; Adele C. Viguera, M.D., M.P.H.; Brittny L. Somley, B.S.; Jennifer K. Koch, M.P.H.; and Lee S. Cohen, M.D.
Background: Postmenopausal women with depression frequently have co-occurring symptoms of hot flashes (vasomotor symptoms), sleep disturbance, anxiety, and pain. Treatment strategies that target all of these symptoms together have not been investigated to date.
Method: Study participants were postmenopausal women, 40 to 60 years old, with major depressive disorder (DSM-IV criteria) and vasomotor symptoms. The study design included a 2-week, single-blind placebo run-in phase followed by an 8-week open-label flexible-dosing (60-120 mg per day) study of duloxetine for women who did not respond to placebo. The primary outcome measure was change in Montgomery-Asberg Depression Rating Scale (MADRS) score during 8 weeks of duloxetine therapy. Secondary outcome measures included changes in vasomotor symptoms, sleep quality, anxiety, and pain. Analyses were conducted using nonparametric methods. Patients were enrolled in the study from May 31, 2005, through May 22, 2006.
Results: Of 30 women eligible to participate in this study, 20 initiated treatment with open-label duloxetine. Fourteen (70.0%) of these women completed the study. There was a statistically significant decrease in MADRS scores after 8 weeks of treatment (p < .001), with scores declining from 19.0 (interquartile range [IQR] = 15.0-21.0) to 5.5 (IQR = 3.0-9.0). There was also a statistically significant improvement in vasomotor symptoms (p = .003), anxiety (p = .002), sleep quality (p < .001), and pain (p < .05).
Conclusions: Postmenopausal women with depression and vasomotor symptoms had significant improvement in depression, vasomotor symptoms, sleep, anxiety, and pain after 8 weeks of open-label duloxetine therapy. Given the common co-occurrence of these symptoms in postmenopausal women, duloxetine may offer important therapeutic benefits for postmenopausal women who have depression and menopause-related symptoms.
(J Clin Psychiatry 2007;68:943-950)
Received Dec. 19, 2006; accepted March 1, 2007. From the Perinatal and Reproductive Psychiatry Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Mass. (Drs. Joffe, Soares, Petrillo, Viguera, and Cohen and Mss. Somley and Koch); and the Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario, Canada (Dr. Soares).
Drs. Joffe and Soares contributed equally as first author.
This study was funded by Eli Lilly Pharmaceuticals.
Presented at the 159th annual meeting of the American Psychiatric Association, May 20-25, 2006, Toronto, Ontario, Canada.
Financial disclosure appears at the end of this article.
Corresponding author and reprints: Hadine Joffe, M.D., M.Sc., Director of Endocrine Studies, Perinatal and Reproductive Psychiatry Program, Massachusetts General Hospital, 185 Cambridge St., Suite 2000, Boston, MA 02114 (e-mail: firstname.lastname@example.org).