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
J Clin Psychiatry 2006;67(2):288-296
© Copyright 2016 Physicians Postgraduate Press, Inc.
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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
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.