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A Double-Blind, Placebo-Controlled Study of Sertraline in the Prevention of Depression in Stroke Patients

Received Oct. 11, 2002; revised Dec. 9, 2002; accepted Jan. 17, 2003. From the Department of Psychiatry, Copenhagen University Hospital, Frederiksberg, Denmark; the Department of Neurology, Copenhagen University Hospital, Hvidovre, Denmark; Pfizer, Ballerup, Denmark; and the Psychiatric Research Unit, Frederiksberg General Hospital, Hillerød, Denmark. Address reprint requests to Dr. Rasmussen, Liaison Psychiatric Department, Copenhagen University Hospital, Bispebjerg Hospital C15, Bispebjerg Bakke 23, 2300 Copenhagen NV, Denmark.

The authors tested the effect of sertraline in the prevention of poststroke depression. After experiencing an acute ischemic stroke, nondepressed patients (N=137) were randomly assigned to 12 months of double-blind treatment with either sertraline (N=70) or placebo (N=67). Kaplan-Meier analysis showed sertraline to have significantly superior prophylactic efficacy compared with placebo. Two definitions of clinical depression were used: total score >18 on the HAM-D₁₇ and score 9 on the HAM-D₆. Approximately 10% of the sertraline-treated group developed depression according to either definition, whereas 30% developed depression in the placebo group. On the HAM-D₆ the superiority of sertraline to placebo was demonstrated already after 6 weeks of therapy. Treatment was well tolerated; patients treated with sertraline experienced significantly fewer adverse events.

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