Depression Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Nexalin Electrical Brain Stimulation for the Treatment of Depression in Patients Referred to Electro-Convulsive Therapy
The purpose of this research study is to determine whether Nexalin Trans-Cranial Electrical
Stimulation (TES) is an effective treatment for depression among patients who are candidates
for ECT. A secondary aim to assess whether Nexalin can be used as an alternative to ECT.
Although Nexalin has been approved for use in the US, using Nexalin to treat depression in
this way is investigational and experimental. If Nexalin is found to be an alternative to
ECT, it could offer a safer treatment for depression with less side-effects and a lower cost.
!!! NOTE !!! Post Script / Post Study. The ECT arm (profiling subjects as ECT accepters vs.
rejecters) was dropped owing to site objections by referring clinicians. Accordingly, the
study was framed as a simple comparison between TES and SHAM TES.
A 2x2 factor Randomized Controlled Trial with block randomization. Inpatient subjects at the Carrier Clinic who are referred for ECT will be recruited, typed regarding their acceptance of ECT, and randomized to either treatment with TES or to a Sham condition. Treatment non-responders in either condition will continue as in patients at the Carrier Clinic until they reach acceptable levels of functioning to be discharged. ;
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