Sertraline in Stroke Patients With Depression J Clin Psychiatry 66:6, June 2005 709 p to one third of poststroke patients seem to suffer from a clinically significant depression, but the 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 fre- quent 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 pa- tients (aged 70.7 ± 9.9 years) were enrolled dur- ing 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 as- sessed, 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 pla- cebo. 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 mea- sured by a conventional depression rating scale improved over time irrespective of treatment. Positive effects specific to sertraline were iden- tified in emotional distress, emotionalism, and QoL. The study indicates that poststroke emo- tional 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). U prevalence varies considerably between studies. 1,2 Two forms of poststroke depression, major and minor, have been reported. 3 Besides the emotional discomfort, depres- sive symptoms appear to have bearings on the patient’s ability to rehabilitate successfully. 4 In a 10-year follow- up, Morris et al. 5 reported that patients who had been depressed in the acute phase of stroke were 3 times more likely to die, and House et al. 6 found a trend toward increased mortality. A 9-year follow-up of patients in- cluded in a short-term randomized placebo-controlled trial (RCT) with nortriptyline or fluoxetine after stroke in- triguingly showed a difference in long-term survival in favor of active treatment. 7 In poststroke depression, an in- creased risk of suicide has also been reported. 8 The pres- ence of depressive and anxiety symptoms also has nega- tive effects on the quality of life. 9,10 Comparatively few RCTs of antidepressant drugs have been made in stroke patients. Short-term studies, with relatively few patients, have been reported for nortripty- line, 11,12 citalopram, 13 and fluoxetine. 12,14 One long-term 708