Double-Blind Comparison of Sertraline and Placebo in Stroke Patients With Minor Depression and Less Severe Major Depression

Veronica Murray, M.D., Ph.D.; Magnus von Arbin, M.D., Ph.D.; Aniko Bartfai, Ph.D.; Anna-Lena Berggren, M.D.; Anne-Marie Landtblom, M.D., Ph.D.; Jöns Lundmark, M.D., Ph.D.; Per Näsman, Ph.D.; Jan-Edvin Olsson, M.D., Ph.D.; Margareta Samuelsson, M.D., Ph.D.; Andreas Terént, M.D., Ph.D.; Riitta Varelius, M.D.; Marie Åsberg, M.D., Ph.D.; and Björn Mårtensson, M.D., Ph.D.

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 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.

(J Clin Psychiatry 2005;66:708-716)

Received April 2, 2004; accepted Feb. 23, 2005. From the Karolinska Institutet Danderyd Hospital, Division of Medicine (Drs. Murray and von Arbin), and the Department of Rehabilitation Medicine, Karolinska University Hospital, Huddinge (Dr. Bartfai), Stockholm; the Department of Medical Sciences, Academic Hospital, Uppsala (Drs. Berggren and Terént); the Department of Neurology (Drs. Landtblom and Olsson) and the Department of Psychiatry (Dr. Lundmark), University Hospital, Linköping; the Royal Institute of Technology, Stockholm (Dr. Näsman); the Departments of Neurology and Geriatric Medicine, University Hospital, Örebro (Drs. Samuelsson and Varelius); and the Department of Clinical Neuroscience, Karolinska Institutet, Stockholm (Drs. Åsberg and Mårtensson), Sweden.

The study was supported by an unrestricted grant, study drug, and placebo from Pfizer AB Sweden and grants from AFA Insurances and Marianne and Marcus Wallenberg Foundation.

Financial disclosure and acknowledgments appear at the end of the article.

Corresponding author and reprints: Veronica Murray, M.D., Ph.D., Karolinska Institutet Danderyd Hospital, Division of Medicine, Danderyd Hospital, S-182 88 Stockholm, Sweden (e-mail: veronica.murray@kids.ki.se).