Soterix Medical has announced a phase III trial for Major Depressive Disorder (MDD), which will compare Soterix Medical's Transcranial Direct Current Stimulation (tDCS) Limited Total Energy (LTE) technology against a fully dosed, effective antidepressant Escitalopram oxalate (Lexapro). The seminal ELECT-TDCS study, initiated by Dr. Andre Brunoni of the University of Sao Paulo, builds on prior work. This work combined tDCS with antidepressant sertraline and concluded "in MDD, the combination of tDCS and sertraline increases the efficacy of each treatment. The efficacy and safety of tDCS and sertraline did not differ."
The initiated phase III ELECT-TDCS study, with a target enrollment of 240 patients, aims to further assess if tDCS-LTE is similarly effective to antidepressant drug medication but with far fewer side-effects. The Soterix Medical 1x1-Clinical Trials (CT) stimulator, equipped with proprietary tDCS-LTE technology, will provide optimized control of stimulation dose and double-blind study-control features calibrated specifically for the study.
Dr. Abhishek Datta, chief technology officer of Soterix Medical, said, "The pivotal ELECT-TDCS neuromodulation study is noteworthy for both its scale and objective to compare with an established drug medication. Most tDCS clinical trials, including the separate ongoing multi-center trial on depression using the Soterix Medical 1x1-CTplatform, evaluate tDCS as a stand-alone therapy. However, Soterix Medical also recognizes that tDCS may be applied in conjunction or as an alternative to drug medication. Many patients suffering from Major Depressive Disorders are insufficiently responsive to medication or suffer side-effects. The ELECT-TDCS study is designed to evaluate if Soterix Medical's non-pharmacological treatment can be as effective as antidepressant drugs. The study will use Soterix Medical's tDCS-LTE and unique EASYstrap platform head-gear."