Dothiepin versus doxepin in major depression: results of a multicenter, placebo-controlled trial. Prothiaden Collaborative Study Group.

BACKGROUND

The tricyclic antidepressant dothiepin is well established in Europe, but clinical experience with the drug in the United States is limited.

METHOD

In a 10-week, multicenter, randomized, double-blind, placebo-controlled study in the United States, the efficacy and tolerability of dothiepin and doxepin (both administered as a 150-mg nightly dose) were compared in 579 outpatients with major depression.

RESULTS

Patients in both active treatment groups showed significant improvements in depressive symptoms, associated anxiety, and sleep parameters compared with the placebo-treated group. The adverse effect profile of dothiepin was superior to that of doxepin, particularly with respect to drowsiness, weight gain, and increased appetite.

CONCLUSION

These results confirm that dothiepin is useful when a tricyclic agent is indicated for the treatment of depression.