Euthymics Bioscience has completed patient enrolment in its Triple Reuptake Inhibitor Anti-Depressant Effects (TRIADE) study of amitifadine (formerly called EB-1010) for major depressive disorder (MDD).
The Phase IIb/IIIa trial is designed to assess the safety and efficacy of amitifadine, a novel serotonin-preferring triple reuptake inhibitor.
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 said.
"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 study has randomised a total of 342 MDD patients at 39 centres in the US and top-line results are expected by the end of the first quarter of 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 (SPCD) was used to enhance the drug-placebo separation signal by reducing placebo response.
Massachusetts General Hospital Psychiatry executive vice chair and TRIADE study principal investigator Dr Maurizio Fava said the study of amitifadine is an ideal opportunity to further explore the triple monoamine concept observed in the STAR*D study.
Sponsored by the National Institute of Mental Health, the STAR*D study is a large seven-year study where combined serotonin, norepinephrine and dopamine reuptake inhibition was shown to improve outcomes in patients with depression not responding to first-line SSRI.