Electrocardiographic Findings in Sertraline Depression Trials

Summary

In 4 studies involving 1048 patients with major depression, the effects of therapeutic doses of sertraline on the electrocardiogram (ECG) were compared with those of placebo and amitriptyline. ECG tracings before and at the end of 4 randomised double-blind clinical trials were evaluated without knowledge of the study medication to which patients had been assigned. In each treatment group, mean changes in heart rate and RR, PR, QRS and QT intervals were assessed, as was the incidence of changes in various ECG parameters from normal at baseline to abnormal at the final reading. The final ECG for each patient was defined as the last ECG recorded during or within 1 day after the period of double-blind therapy. There were no significant differences in any overall comparison between the sertraline and placebo groups, except for sinus arrhythmia, which was more common in the placebo group. Amitriptyline, compared with sertraline and placebo, significantly increased the heart rate and shortened the RR and QT intervals (p < 0.001). In addition, the incidence of conversion to sinus tachycardia was significantly greater in the amitriptyline group than in the placebo group. Except for conversions in rhythms (mainly from conversions in the sertraline and placebo groups to sinus bradycardia and in the amitriptyline group to sinus tachycardia), the incidence of conversions for all other ECG parameters and for all treatment groups was low and without clinical significance. ECG findings in the elderly were essentially like those noted in nonelderly patients. The results of these analyses show that sertraline has no significant effect on the clinical ECG.