Transcranial Laser Therapy for Major Depressive Disorder (ELATED)
|ClinicalTrials.gov Identifier: NCT01538199|
Recruitment Status : Completed
First Posted : February 24, 2012
Results First Posted : November 29, 2017
Last Update Posted : November 29, 2017
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)
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: Near-infrared radiation via Transcranial LED Therapy Device: Sham device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Experimental: TLT Treatment Group 1
The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks
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.
Sham Comparator: TLT Treatment Group 2
The sham group will receive 2 treatments of the sham device per week for 8 weeks
Device: Sham device
The sham device does not emit near-infrared radiation.
Other Name: PhotoMedex Omnilux New-U.
- Change in Hamilton Depression Rating Scale (HAM-D 17) Score [ Time Frame: Visit 1 (Baseline) and Visit 17 (Week 9); Pilot Phase: Visit 1 (Baseline) and Week 8 ]
We anticipate that TLT will decrease HAM-D17 scores in study subjects significantly more than Sham treatment. We expect that we will be also able to estimate the effect size of the antidepressant action of TLT. Analyses were done for all evaluable subjects (participants who met the a priori cut-off of a minimum of 4 t-PBM sessions for inclusion in the study analyses) and treatment completers (participants followed for the entire 8-week study period and who received a clinical assessment immediately after).
HAM-D17 questions are rated on a scale of 0-4 or 0-2 (total score: 0-50) with higher scores indicating more severe pathology. Scores typically fall into the following ranges: not depressed = 0-7; mildly depressed = 8-13; moderately depressed = 14-18; severely depressed = 19-22; very severely depressed = 23 and over.
For the pilot study, we analyzed subjects from Baseline to Week 8. A last observation carried forward (LOCF) was performed to account for one week 8n missing value.
- Systematic Assessment for Treatment Emergent Events-systematic Inquiry (SAFTEE-SI) [ Time Frame: Assessed at odd-numbered Visits 1-17. The single value to be analyzed is the number of distinct side effects that occurred at least once during these assessment visits for each subject. ]
To assess the safety and tolerability of TLT in depressed subjects: We predict that TLT will be safe and well-tolerated, as assessed by the SAFTEE-SI. We anticipate no significant differences between TLT and Sham in side-effects.The SAFTEE is a commonly used instrument developed by the NIMH and adapted into a self-report instrument. The version we used is the same used by the NIMH-sponsored CO-MED trial. It examines all possible treatment-emergent side effects and adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior.
The SAFTEE analyses are ongoing and will be reported in a second paper (they are not included in the primary outcomes paper). The single value analyzed is the total number of distinct treatment-emergent side-effects (a side effect is defined as any item on the SAFTEE for which severity increased by two or more levels from baseline to any visit) that occurred for each subject. Range: 0 to 165; higher values represent worse outcomes.
- Number of Participants With Adverse Events [ Time Frame: Visits 1, 3, 5, 7, 9, 11, 13, 15, and 17 ]
To assess the safety and tolerability of the TLT in depressed subjects: We predict that the TLT will be safe and well-tolerated by depressed patients, as assessed by the following rating scales: ADVERSE EVENTS FORM. We anticipate no significant differences in between TLT and Sham treatment as concerns side-effects.
Due to the small sample size and the variability of reported adverse events, we decided that descriptive reporting (i.e. reporting each subject's adverse events individually) was more appropriate than analysis. All adverse events were reported in the adverse events section. In the outcome measure data table below we report the number of participants in each group who experienced an adverse event.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538199
|United States, Massachusetts|
|Massachusetts General Hospital- Depression Clinical and Research Program|
|Boston, Massachusetts, United States, 02114|
|Chelsea Counseling Center- North Suffolk Mental Health Association|
|Chelsea, Massachusetts, United States, 02150|
|Principal Investigator:||Paolo Cassano, MD, PhD||Massachusetts General Hospital, Harvard Medical School, and North Suffolk Mental Health Association|