New statistical proposals to evaluate the benefit/risk ratio of long-term treatment of depression: application to a one-year double-blind study comparing medifoxamine with fluoxetine.

Abstract

The aim of this study was to determine the benefit/risk ratio of long-term treatment with medifoxamine, a non-tricyclic, non-monoamine oxidase inhibitor agent, and fluoxetine in patients with acute depressive episode and at high risk of relapse and/or recurrence. The study involved a 12-month double-blind, randomised, parallel-group design with a multicentric trial setting conducted by 64 participating physicians. 155 and 158 patients of either gender, aged between 18 and 70 years, were allocated to fluoxetine and medifoxamine, respectively. All patients had an acute depressive episode defined by the presence of at least five of the DSM III-R criteria with a minimal score of 25 on the Montgo..