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A Double-Blind, Multicenter, Parallel-Group Study of Paroxetine, Desipramine, or Placebo in Breast Cancer Patients (stages I, II, III, and IV) With Major Depression
Dominique L. Musselman, M.D.; Wendy I. Somerset, M.D.; Ying Guo, Ph.D.; Amita K. Manatunga, Ph.D.; Maryfrances Porter, M.A.; Suzanne Penna, Ph.D.; Barbara Lewison, B.A.; Rebecca Goodkin, M.D.; Kathryn Lawson, M.S.; David Lawson, M.D.; Dwight L. Evans, M.D.; and Charles B. Nemeroff, M.D., Ph.D.
Objective: This study compared the efficacy and safety of paroxetine and desipramine with those of placebo in the treatment of depressive disorders in adult women with breast cancer, stages I-IV.
Method: In a double-blind, placebo-controlled study, 35 female outpatients with breast cancer and DSM-III-R major depression or adjustment disorder with depressed mood were randomly assigned to treatment with paroxetine (N = 13), desipramine (N = 11), or placebo (N = 11) for 6 weeks. Primary efficacy was assessed by change from baseline in score on the 21-item Hamilton Rating Scale for Depression (HAM-D), and the secondary outcome measure was change from baseline in the Clinical Global Impressions-Severity of Illness scale (CGI-S) score.
Results: Mean changes in the total HAM-D and CGI-S scores from baseline to 6-week endpoint for the paroxetine and desipramine groups were not significantly different than those for the placebo-treated group. An unusually high rate of response (defined as >= 50% improvement in the HAM-D score) in the placebo group was observed (55% [N = 6]); adverse events precipitated patient discontinuation in the active treatment groups (9% [N = 1] for desipramine, 15% [N = 2] for paroxetine) similar to that in the placebo-treated patients (18% [N = 2]). Improvement on symptom dimensions within the HAM-D and Hamilton Rating Scale for Anxiety (depressive, anxiety, cognitive, neurovegetative, or somatic) was also similar between groups.
Conclusion: The small number of women in this study most likely contributed to the lack of observed differences in efficacy observed during the 6 weeks of treatment. Randomized, placebo-controlled trials of adequate power seeking to determine efficacy of antidepressants in the United States for the treatment of women with breast cancer and comorbid depression remain of paramount importance.
(J Clin Psychiatry 2006;67:288-296)
Received Feb. 10, 2005; accepted Oct. 8, 2005. From the Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine (Drs. Musselman, Somerset, and Nemeroff and Mss. Lewison and Lawson), the Department of Biostatistics, Rollins School of Public Health (Drs. Guo and Manatunga), and the Department of Medicine, Division of Medical Oncology, Winship Cancer Institute (Dr. Lawson), Emory University, Atlanta, Ga.; the Department of Psychology, University of Virginia School of Medicine, Charlottesville (Ms. Porter); the Department of Psychology, Georgia State University, Atlanta (Dr. Penna); the Department of Surgery, University of Virginia, Roanoke (Dr. Goodkin); and the Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia (Dr. Evans).
This study was funded by financial and material support from GlaxoSmithKline, King of Prussia, Pa. Statistical support was provided by the Emory University Hospital General Clinical Research Center and grant MO1-RR00039 from the National Institutes of Health, Bethesda, Md.
Financial disclosure is listed at the end of this article.
Corresponding author and reprints: Charles B. Nemeroff, M.D., Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Woodruff Research Memorial Building, 101 Woodruff Circle, Suite 4000, Atlanta, GA 30322 (e-mail: email@example.com).