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

Author(s): Ferguson JM, Mendels J, Manowitz NR

Affiliation(s): Pharmacology Research Corporation, Salt Lake City, UT 84107-7591.

Publication date & source: 1994-06, J Clin Psychiatry., 55(6):258-63.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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.

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