Major Depressive Disorder Clinical Trial
Official title:
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
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)
TLT has previously been evaluated in two large studies of people who have had a stroke. To
date, TLT has been administered to over 550 people who have had a stroke. TLT has also been
used in 10 people with MDD who were taking part in a research study. During this study, TLT
was shown to relieve MDD symptoms without causing too many side effects.
The -Infrared Radiation (NIR) device is also marketed for wrinkles treatment, however it is
experimental for the use in depression. An experimental device means that it is one that has
not been approved by the U.S. Food and Drug Administration (FDA).
During this study, the investigators hope to better find out if NIR TLT is helpful for
treating depression. The investigators will do this by comparing the effects of TLT ("active
treatment") NIR device to a sham treatment (which is an inactive or "pretend" treatment)
device. The sham ("pretend") device looks exactly like the NIR device but will not use a
near-infrared radiation during the study visits. There are two sets of identical devices that
will be used in this study, producing active and sham treatment, respectively. The devices
work exactly the same when you are receiving active treatment and sham treatment, except that
the devices will produce therapeutic transcranial LED energy during the active treatment
sessions but it will not produce this LED energy during the sham treatment sessions.
The investigators hope to enroll about 30 subjects in this study at the Massachusetts General
Hospital Depression Clinical and Research Program.
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