e-Therapeutics Begins IIb Tramadol CR trial

e-Therapeutics has begun a randomized, double-blind, controlled Phase IIb trial of ETS6103 in major depressive disorder. The trial is evaluating ETS6103 as a second-line treatment for patients who have not responded adequately to first-line therapy with an SSRI (selective serotonin reuptake inhibitor). It is being conducted by a group of primary care centers with a history of involvement in depression studies in the Glasgow area of Scotland.

ETS6103 is a controlled-release formulation of tramadol. Under the trial protocol, patients are enrolled prior to first-line treatment so that this can be standardized: every patient will receive the SSRI Celexa (citalopram). Those with significant depressive symptoms remaining after six weeks on citalopram will enter the randomized phase of the study, which compares two different doses of ETS6103 with amitriptyline, a widely available tricyclic antidepressant. Approximately 160 patients will be randomized.

The principal objective is to test whether the two ETS6103 regimens have antidepressant activity ’non-inferior’ to that of amitriptyline. The primary measure of activity is the change in Montgomery–Åsberg Depression Rating Scale (MADRS) score between randomization and the end of treatment eight weeks later. Safety and a variety of secondary efficacy variables will also be assessed. e-Therapeutics expects to report the results of the trial in the first half of 2015. If these are positive, the company intends to seek a licensing deal for the drug.