Double-Blind Comparison of Sertraline and Placebo in Stroke Patients With Minor Depression and Less Severe Major Depression
J Clin Psychiatry 2005;66(6):708-716
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: Poststroke depression is a frequent
condition and important to treat. The aim of this trial was to
study the efficacy and tolerability of sertraline.
Method: In 4 Swedish stroke centers, 123
patients (aged 70.7 ± 9.9 years) were enrolled during the period
September 1998 to January 2001 in a randomized, double-blind,
placebo-controlled 26-week trial, at a mean of 128 ± 97 days
(range, 3-375 days) after stroke, if they fulfilled DSM-IV
criteria of major depressive episode (N = 76) or minor depressive
disorder (N = 47). The primary efficacy variable was a change in
depression assessed by the Montgomery-Åsberg Depression Rating
Scale. The Emotional Distress Scale (EDS) was administered and
the occurrence of emotionalism and quality of life (QoL) were
assessed, as well as neurologic recovery. Efficacy analyses were
intention-to-treat, short-term (week 6) and long-term (week 26).
Results: Of the 123 patients, 62 were treated
with sertraline (50-100 mg/day) and 61 with placebo. Both groups
improved substantially, with no differences between the
treatments, either for major depressive episode or minor
depressive disorder, or for short- or long-term antidepressant
effect and neurologic outcome. EDS revealed a better outcome with
sertraline at week 6 (p < .05). At week 26, the improvement in QoL was better in sertraline patients (p < .05) and there was a
trend for emotionalism (p = .07). No serious side effects were
Conclusion: Poststroke depression as measured by
a conventional depression rating scale improved over time
irrespective of treatment. Positive effects specific to
sertraline were identified in emotional distress, emotionalism,
and QoL. The study indicates that poststroke emotional reactions
comprise depression and other domains susceptible to