Double-blind comparison of sertraline and placebo in stroke patients with minor depression and less severe major depression

J Clin Psychiatry. 2005 Jun;66(6):708-16. doi: 10.4088/jcp.v66n0606.

Abstract

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-Asberg 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 seen.

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 pharmacologic therapy.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Ambulatory Care
  • Depressive Disorder / drug therapy*
  • Depressive Disorder / etiology
  • Depressive Disorder / psychology
  • Depressive Disorder, Major / drug therapy
  • Depressive Disorder, Major / etiology
  • Depressive Disorder, Major / psychology
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Placebos
  • Serotonin Uptake Inhibitors / therapeutic use*
  • Sertraline / therapeutic use*
  • Severity of Illness Index
  • Stroke / complications*
  • Stroke / psychology
  • Treatment Outcome

Substances

  • Placebos
  • Serotonin Uptake Inhibitors
  • Sertraline