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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Euthymics Bioscience, Inc. today announced top-line results from TRIADE (Triple Reuptake Inhibitor Anti-Depressant Effects), a phase 2b/3a clinical study designed to assess the safety and efficacy of amitifadine in patients with major depressive disorder (MDD) failing to respond to one course of first-line antidepressants. Amitifadine is a novel serotonin-preferring triple reuptake inhibitor antidepressant. In TRIADE, amitifadine efficacy at 50 or 100 mg doses did not show a statistically significant difference from placebo in the primary endpoint of a change in MADRS (Montgomery–Åsberg Depression Rating Scale). However, an active comparator arm shows the study itself did work, and the dose range for amitifadine may have been too low. Further, the lack of side effects with the 100 mg dose, combined with signs of efficacy in several post-hoc analyses, suggests that higher doses may show benefit in the target MDD patient group.
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