At a glance
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Evaluation of LED Therapeutic Effect in Depression (ELATED): a Placebo-Controlled, Parallel Study of Efficacy, Tolerability and Acceptability of a Novel Approach in the Community
In Brief
A clinical study evaluating Near-infrared radiation via Transcranial LED Therapy and Sham device for Major Depressive Disorder. Completed, enrolled 28 participants across 2 sites.
Detailed Summary
The purpose of this study is to see if using Transcranial LED Therapy (TLT) using the PhotoMedex's Omnilux NEw-U LED helps improve symptoms of major depressive disorder (MDD). TLT works by briefly delivering near-infrared (non-visible) radiations to the forehead. The radiations penetrate the brain and stimulate the cells \& metabolism. Our goals are * To assess the antidepressant effect of the TLT in depressed subjects. * To assess the safety and tolerability of the TLT in depressed subjects * To assess the acceptability of the TLT in depressed subjects * To pilot test the impact on cognition of the TLT in depressed subjects (Ancillary Study)
Study Details
Timeline
Interventions
The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads. The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject.
The sham device does not emit near-infrared radiation.