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Transcranial Laser Therapy for Major Depressive Disorder

NCT01538199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-11-29

Study results available
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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)

Conditions

Interventions

DEVICE

Near-infrared radiation via Transcranial LED Therapy

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.

DEVICE

Sham device

The sham device does not emit near-infrared radiation.

Sponsors & Collaborators

  • Mclean Hospital

    collaborator OTHER

  • North Suffolk Mental Health Association

    collaborator OTHER

  • Paolo Cassano

    lead OTHER

Principal Investigators

  • Paolo Cassano, MD, PhD · Massachusetts General Hospital, Harvard Medical School, and North Suffolk Mental Health Association

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01538199 on ClinicalTrials.gov