Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n°105

Report positive results from two double-blind

Posted by fidest press agency su domenica, 15 aprile 2018

Soterix Medical Inc (SMI) is pleased to report positive results from two double-blind, sham-controlled clinical trials of its proprietary transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) technology for the treatment of depression. The Depression tDCS-LTE system is unique in providing drug-free therapy with minimal side effects while maximizing energy delivery to the dorsolateral prefrontal cortex (DLPFC) region, which is implicated in depression control.
The first clinical trial reported tDCS-LTE was an effective, safe, and tolerable add-on intervention in patients with type I or II bipolar disorder in a major depressive episode and receiving a stable pharmacologic regimen. In this 59 patient randomized, sham-controlled, double-blind trial, tDCS-LTE produced an average 14-point improvement in Hamilton Depression Rating Scale (HDRS-17) scores, after just 12 treatments. The benefit persisted for over a month, with common side-effects no different than placebo. The results of the “Bipolar Depression Electrical Treatment Trial [BETTER]” were published in JAMA Psychiatry.The second clinical trial reported tDCS-LTE to be superior to placebo producing an average 8 point decrease in the HDRS-17 after 15 consecutive weekdays of treatment (the induction phase), followed by 7 weekly treatments (the taper phase). In this 245 patient double-blind trial, patients received tDCS-LTE plus oral placebo, sham tDCS-LTE plus escitalopram (an SSRI drug), or sham tDCS-LTE plus oral placebo. The tDCS-LTE group had higher rates of itching or tingling, tinnitus, and nervousness than the other groups. The drug group side-effects included sleeplessness and severe constipation. At the trial endpoint, as the tDCS-LTE dose was tapered to weekly while escitalopram was maintained at a high daily dose, patients who received tDCS-LTE maintained significantly improved HDRS-17 scores compared to placebo while patients on high-dose escitalopram had slightly more improved HDRS-17 with noted side-effects. The results of the “ELECT-tDCS” trial were published in New England Journal of Medicine.
Physicians in the EU, Singapore, Australia, and Brazil interested in providing Soterix Medical Depression tDCS-LTE therapy are eligible for the Soterix Medical’s Partnership program which includes support on the entire patient treatment pipeline, hands-on training and staff certification, and connection to our network of physician researchers.


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