What Happens With Adverse Events During 6 Months of Treatment With Selective Serotonin Reuptake Inhibitors?
J Clin Psychiatry 2005;66(7):859-863
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Objective: Although adverse events are a key
factor in compliance, their evolution during treatment with
antidepressants is poorly documented. Therefore, the time course
of adverse events during 6 months of antidepressant treatment was
Method: 85 psychiatric outpatients with a DSM-IV
diagnosis of major depressive disorder (with the exclusion of
other DSM-IV Axis I disorders) were enrolled between September
2002 and March 2003 in a multicenter, randomized, double-blind
trial with selective serotonin reuptake inhibitors (fluoxetine
[N = 42] and paroxetine [N = 43]). At each visit, the presence and
severity of treatment-emergent adverse events were assessed
systematically using the UKU Side Effect Rating Scale (UKU).
General linear mixed modeling was used to investigate the
predictors of the time course of adverse events.
Results: Overall, the number of at least
moderately severe adverse events decreased with time. More
severely depressed patients reported overall more (at least
moderately severe) adverse events than less severely depressed
patients (p = .0002), but the decrease in reported adverse events
was comparable over time. Men (N = 30) and women (N = 55) reported
initially the same number of at least moderately severe adverse
events, but the habituation was more rapid in men (p < .0001).
Completers (N = 58) and dropouts (N = 27) did not differ initially,
but completers' habituation was more rapid (p = .014). The
habituation of adverse events was also more rapid in recurrent
than in first-episode patients but only in men (p = .0025).
Conclusion: The time course of adverse events
varies with the severity of depression, sex, completer or dropout
status, and recurrent versus first-episode depression.