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.