Navigation Links
Soterix Medical Inc. announces Phase 3 Clinical Trial for Depression comparing tDCS-LTE against antidepressant drug (Escitalopram)

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 ( 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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Soterix Medical Inc. reports positive results from High-Definition tDCS Fibromyalgia Trial at Harvard Medical School
2. Securus Medical Group Raises $6.5M, Appoints New CEO
3. Nonin Medical Appoints Richard J. Eagle Vice President of Sales
4. Solta Medical to Report Third Quarter 2013 Results and Host Conference Call on November 11, 2013
5. Utah Hospital Saves Money and the Environment by Treating Its Own Medical Waste on Site
6. Medical Imaging Equipment Market is Expected to Reach USD 35.35 Billion Globally in 2019: Transparency Market Research
7. Epiditi - "COOL THE JEWELS!" The Only Form-Fitting Scrotal Ice Pack on the Planet - Now A Medical Crowdfunding Project
8. Middle Peak Medical Raises an Additional $3M to Develop Novel Mitral Valve Technology
9. Aethlon Medical (AEMD) Note: Cancer Immunotherapy Article, Introduction to Dr. Douglas Taylor
10. Media Sourcerys Secure Mobile Workflow App Deployed by CCS Medical to Expedite Product Delivery to Patients
11. Varian Medical Systems Reports Results for Fourth Quarter of Fiscal Year 2013
Post Your Comments:
(Date:6/24/2016)... ALEXANDRIA, Va. , June 24, 2016 ... a set of recommendations that would allow ... information (HCEI) with entities that make formulary and coverage ... determine the "value" of new medicines. The ... that does not appear on the drug label, a ...
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ... company developing innovative inhaled drugs, announced today that it ... Russell Investments reconstituted its comprehensive set of U.S. ... "This is an important milestone for Pulmatrix," said ... increase shareholder awareness of our progress in developing drugs ...
(Date:6/23/2016)... BEVERLY HILLS, Calif. , June 23, 2016 ... faced the many challenges of the current process. Many of ... option because of the technical difficulties and high laboratory costs ... would have to offer it at such a high cost ... to afford it. Dr. Parsa Zadeh , ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... ... TherapySites, the leading website and online marketing ... Association. This new relationship allows TherapySites to continue to extend their online ... and promotional offers. , "TCA is extremely excited about this new partnership, as ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a ... and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is ... to some of the world’s leading providers of cereal and other breakfast foods. Its ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the ... several important health care topics including advance care planning, healthcare costs and patient ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, ... and his M.D from the David Geffen School of Medicine at UCLA. He trained ... Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set ... drug or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, ... traumatic event. , Trauma sufferers tend to feel a range of emotions, from depression, ...
Breaking Medicine News(10 mins):