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, Wendy I. Somerset, Ying Guo, Amita K. Manatunga, Maryfrances Porter, Suzanne Penna, Barbara Lewison, Rebecca Goodkin, Kathryn Lawson, David Lawson, Dwight L. Evans, Charles B. Nemeroff

Research output: Contribution to journalArticle

60 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)288-296
Number of pages9
JournalJournal of Clinical Psychiatry
Volume67
Issue number2
DOIs
StatePublished - Feb 2006

ASJC Scopus subject areas

  • Psychiatry and Mental health

Fingerprint Dive into the research topics of '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'. Together they form a unique fingerprint.

  • Cite this