An open-label preliminary trial of sertraline for treatment of major depression after acute myocardial infarction (the SADHAT Trial)

Background Depression occurs frequently in patients with acute myocardial i nfarction and is associated with increased mortality rates. it is not known whether serotonin reuptake inhibitors would be safe and effective for pati ents with depression after myocardial infarction and whether such treatment would reduce mortality rates. Methods and Results we conducted a multicenter, open-label, pilot study of sertraline treatment in patients with major depressive disorder identified 5 to 30 days after admission for acute myocardial infarction. Outcome measu res included cardiovascular and hemostatic function, adverse events, and mo od ratings. Twenty-six patients were enrolled in the study. During treatmen t there were no significant changes in heart rate, blood pressure, cardiac conduction, or left ventricular ejection fraction, and there was a trend to ward reduced ventricular ectopic activity. There were no changes in coagula tion measures. Bleeding time increased in 12 patients, decreased in 4 patie nts, and was unchanged in 2 patients. Three (12%) patients withdrew from tr eatment prematurely because of adverse events. Significant improvements in mood ratings occurred over the course of treatment. Conclusions Sertraline treatment was associated with clinical improvement a nd was well tolerated in >85% of the patients in this open-label treatment trial for patients with major depression after myocardial infarction. These results encourage further controlled trials to establish the effects of tr eatment for this high-risk population.