NEW YORK, Oct. 29, 2013 /PRNewswire/ -- Soterix Medical Inc. announces today a Phase 3 trial for Major Depressive Disorder (MDD) that 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 (cinausp.org) builds on prior work published in 2013 in JAMA Psychiatry. 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 3 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. For this trial, 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. View the LTE paper here.
Dr. Abhishek Datta, CTO of Soterix Medical summarizes "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. Indeed, many patients suffering from Major Depressive Disorders are insufficiently responsive to medication or suffer side-effects. The ELECT-TDCS study is designed by world leading clinical researchers to evaluate if Soterix Medical's unique non-pharmacological treatment can be as effective as antidepressant drugs. The study will use Soterix Medical's ground-breaking Transcranial Direct Current Stimulation Limited Total Energy (tDCS-LTE) and unique EASYstrap platform head-gear. The Soterix Medical tDCS-LTE platform is the only neuromodulation technology designed for robustness, practical scalability, and broad deployment."
CAUTION: tDCS is limited by Federal (or United States) law to investigational use only.
BACKGROUND: tDCS- Limited Total Energy (tDCS-LTE) is an exclusive neuromodulation technology developed by Soterix Medical Inc. Invented at The City College of New York, tDCS-LTE is the only tDCS technology platform optimized for robust low-energy Transcranial Direct Current Stimulation. tDCS-LTE is under investigation in susceptible populations including stroke, pediatric, traumatic brain injury, etc. tDCS-LTE is made possible through a proprietary adaptive stimulation limiting the voltage and power required for tDCS. Soterix Medical tDCS-LTE is the only non-invasive neuromodulation technology further optimized for robust deployment in a wide variety of environments including emergency medicine, field-work, home-use, etc.
Major Depressive Disorder or Major Depression is characterized by a combination of symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Major Depression is disabling and prevents a person from functioning normally. Some people may experience only a single episode within their lifetime, but more often a person may have multiple episodes. Major Depression affects about 6.7% of the U.S. population over age 18, according to the National Institute of Mental Health. Overall, between 20% and 25% of adults may suffer an episode of Major Depression at some point during their lifetime.
Escitalopram (Lexapro®): According to the National Institutes of Health: "Escitalopram is used to treat Depression and Generalized Anxiety Disorder (GAD; excessive worry and tension that disrupts daily life and lasts for 6 months or longer) Escitalopram may cause side effects [including] nausea, diarrhea, constipation, changes in sex drive or ability, drowsiness, increased sweating, dizziness, heartburn, stomach pain, excessive tiredness, dry mouth, increased appetite, flu-like symptoms, runny nose, sneezing. Antidepressants increase the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders." A full list of mild and serious potential side-effects can be found here.
Soterix Medical Inc. is a leader in non-invasive electrical neuromodulation based in New York City committed to developing innovative medical therapies. Soterix Medical Inc. supports clinical trials aimed at treatment of neuropsychiatric disorders using device-based non-pharmacological treatment. See full-listing of trials using Soterix Medical technology here.
SOURCE Soterix Medical Inc.