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news.Euthymics Bioscience has completed enrolment in Triple Reuptake Inhibitor Anti-Depressant Effects (TRIADE) study of a novel serotonin-preferring triple reuptake inhibitor amitifadine for major depressive disorder (MDD).
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The Phase 2b/3a trial, designed to assess the safety and efficacy of amitifadine, has randomised a total of 342 MDD patients at 39 centres in the US.
Euthymics president and CEO Anthony McKinney said amitifadine is being developed as a broad spectrum antidepressant for primary care physicians and psychiatrists to use after the patient fails to respond to a course of first-line antidepressants.
"TRIADE is designed to support use of amitifadine as the next step once patients have failed initial therapy," McKinney added.
"This ‘first of second-line’ approach proposes amitifadine as a monotherapy for use after first-line generic antidepressants have failed but before more complex and costly drug combinations are tried."
The company expects top-line results from the study by the end of first quarter 2013.
TRIADE evaluated amitifadine for patients with MDD who did not respond adequately to one and only one course of first-line antidepressants such as selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, bupropion or tricyclic antidepressants.
Advanced clinical trial techniques were incorporated to reduce placebo effects and ensure quality control in patient selection while the Sequential Parallel Comparison Design was used to enhance the drug-placebo separation signal by reducing placebo response.