Phase III Trial To Evaluate tDCS-LTE In Combination With Escitalopram
Espicom View: With previous data demonstrating the efficacy and reduced side effects of Soterix Medical's neuromodulation technology in combination with antidepressants, it is anticipated that this study will achieve similar results. A new treatment option will give hope to people with major depressive disorder who suffer severe side effects or do not respond to drug treatment alone. BMI 's Burden of Disease Database estimates that 5,069,114.6 disability-adjusted life years will be lost to depression in 2013, and expects this to rise to 5,264,641.6 in 2020. There is clear need in the US and globally for effective treatments for depression sufferers that also limit treatment-related side effects.
A Phase III trial in major depressive disorder (MDD) that will compare Soterix Medical's transcranial direct current stimulation (tDCS) limited total energy (LTE) technology with a fully dosed, effective antidepressant, escitalopram (Lexapro, marketed by Forest Laboratories), has begun. Additionally, the trial will assess the efficacy and side effect profile of tDCS-LTE in conjunction with escitalopram.
The seminal ELECT-TDCS study, initiated by Dr Andre Brunoni of the University of Sao Paulo, Brazil, builds on prior work published in 2013 in JAMA Psychiatry (2013;70: 383-391). This work combined tDCS with the 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'. ELECT-TDCS, with a target enrolment of 240 patients, aims to further assess if tDCS-LTE is similarly effective to antidepressant drug medication but with far fewer side effects. As well as treatment resistance, common side effects related to antidepressant drug therapies include feeling anxiety and agitation, nausea, gastrointestinal problems, diarrhoea, loss of appetite, insomnia, headaches, erectile dysfunction and loss of sex drive.
For this trial, the Soterix 1x1-Clinical Trials (CT) stimulator, equipped with tDCS-LTE technology, will provide optimised control of stimulation dose and double-blind study control features calibrated specifically for the study. ELECT-TDCS is noteworthy for both its scale and objective to compare with an established drug therapy. Most tDCS clinical trials, including a separate, ongoing multicentre trial in depression using the Soterix 1x1-CT platform, evaluate tDCS as a stand-alone therapy. However, Soterix also recognises that tDCS may be applied in conjunction or as an alternative to drug medication. Indeed, many patients suffering from MDD are insufficiently responsive to medication or suffer side effects. ELECT-TDCS is designed to evaluate if Soterix' non-pharmacological treatment can be as effective as antidepressant drugs. The study will use the company's tDCS-LTE and EASYstrap platform head-gear. The tDCS-LTE platform is believed to be the only neuromodulation technology designed for robustness, practical scalability and broad deployment.
tDCS-LTE is currently under investigation in susceptible populations, including stroke, paediatric, traumatic brain injury and others. The technology employs proprietary adaptive stimulation, limiting the voltage and power required for tDCS.