Transcranial Photobiomodulation for the Treatment of Major Depressive Disorder. The ELATED-2 Pilot Trial

Abstract

Objective: Our objective was to test the antidepressant effect of transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light in subjects suffering from major depressive disorder (MDD). Background: t-PBM with NIR light is a new treatment for MDD. NIR light is absorbed by mitochondria; it boosts cerebral metabolism, promotes neuroplasticity, and modulates endogenous opioids, while decreasing inflammation and oxidative stress. Materials and methods: We conducted a double-blind, sham-controlled study on the safety and efficacy (change in Hamilton Depression Rating Scale [HAM-D 17 ] total score at end-point) of adjunct t-PBM NIR [823 nm; continuous wave (CW); 28.7 · 2 cm 2 ; 36.2 mW/cm 2 ; up to 65.2 J/cm 2 ; 20-30 min/session], delivered to dorsolateral prefrontal cortex, bilaterally and simultaneously, twice a week, for 8 weeks, in subjects with MDD. Baseline observation carried forward (BOCF), last observation carried forward (LOCF), and completers analyses were performed. Results: The effect size for the antidepressant effect of t-PBM, based on change in HAM-D 17 total score at endpoint, was 0.90, 0.75, and 1.5 (Cohen's d), respectively for BOCF (n = 21), LOCF (n = 19), and completers (n = 13). Further, t-PBM was fairly well tolerated, with no serious adverse events. Conclusions: t-PBM with NIR light demonstrated antidepressant properties with a medium to large effect size in patients with MDD. Replication is warranted, especially in consideration of the small sample size.

Effects of transcranial photobiomodulation with near‐infrared light on sexual dysfunction

“…Recruitment began in February 2014, and the study was completed in August 2015. The ELATED-2 clinical trial has already been described in detail [19].…”

“…Adult subjects (age 18-65 years) meeting the DSM-IV SCID criteria for MDD, with the degree of depression severity rated at least moderate (Hamilton Depression Rating Scale, HAM-D 17 total score ranging [14][15][16][17][18][19][20][21][22][23][24], were included in the study after providing written informed consent. During the current episode, subjects could have failed no more than one FDA-approved antidepressant medication (for at least 6 weeks) and no more than one course of structured psychotherapy for depression (for at least 8 weeks).…”

“…Photomedex, Inc. provided the blinding codes of NIR and sham, which were kept in a sealed envelope at the study site, for each labeled pair of devices. Prior to this secondary paper, the blinding in ELATED-2 had already been tested, and there were no significant correlations between treatment assignment and the guess made by the subjects as to which treatment they were receiving [19].…”

Photochromotherapy using narrow-band optical radiation of 530 nm wavelength in cognitive rehabilitation of patients with focal brain lesions

“…Отмечалось лишь одно достоверное (р < 0,05) различие: в группе ФХТ прирост баллов по модифицированной шкале Рэнкина составил в среднем 1,5 балла при контрольных значениях 1,1 балла. При этом наблюдался относительно больший прирост внимания в тесте Шульте (27,8 однако это различие не достигало уровня достоверного (р = 0,07). Данные, представленные в табл.…”

Transcranial Photobiomodulation with Near-Infrared Light from Childhood to Elderliness: Simulation of Dosimetry

“…15 A wide range of studies, in both animal models and humans, have shown that PBM causes minimal or no adverse effects while producing therapeutic effects. 10,16,17 Although MDD has a broad age of onset, 2,4 most previously published studies have focused on t-PBM treatments in only middle-aged adult brain models. 18 However, personalization of treatments is key to increasing success rate and tolerability; therefore our interest is in developing precise PBM treatment strategies adapted for individual patients.…”