TY - JOUR
T1 - Transcranial Photobiomodulation for the Treatment of Major Depressive Disorder. the ELATED-2 Pilot Trial
AU - Cassano, Paolo
AU - Petrie, Samuel R.
AU - Mischoulon, David
AU - Cusin, Cristina
AU - Katnani, Husam
AU - Yeung, Albert
AU - De Taboada, Luis
AU - Archibald, Abigal
AU - Bui, Eric
AU - Baer, Lee
AU - Chang, Trina
AU - Chen, Justin
AU - Pedrelli, Paola
AU - Fisher, Lauren
AU - Farabaugh, Amy
AU - Hamblin, Michael R.
AU - Alpert, Jonathan E.
AU - Fava, Maurizio
AU - Iosifescu, Dan V.
N1 - Funding Information:
Dr. Cassano’s salary was supported by the Harvard Psychiatry Department (Dupont-Warren Fellowship and Livingston Award), by the Brain and Behavior Research Foundation (NARSAD Young Investigator Award) and by the Photothera, Inc. unrestricted grant. Drug donation was from TEVA. Travel reimbursement was from Pharmacia-Upjohn. Dr. Cassano has received consultation fees from Janssen Research and Development. Dr. Cassano has filed a provisional patent related to the use of near-infrared light in psychiatry. PhotoMedex, Inc. supplied four devices for this clinical study. Since completion of the study and of the article, Dr. Cassano is/has (1) received unrestricted funding from Litecure, Inc. to conduct an additional study on tran-scranial photobiomodulation for the treatment of major depressive disorder; (2) received unrestricted funding from Cerebral Sciences to conduct a study on transcranial pho-tobiomodulation for the treatment of generalized anxiety disorder; (3) co-founded, member of the board of directors and consultant of Niraxx Light Therapeutics, Inc., a company focused on the development of new modalities of treatment based on near-infrared light.
Funding Information:
The Harvard Psychiatry Department (Dupont-Warren Fellowship and Livingston Award) and the Brain and Behavior Research Foundation (NARSAD Young Investigator Award; Grant No. 19159) supported this investigation. Two pairs of study devices (active and sham) were provided by Photo-medex, Inc. (Orangeburg, NY), and underwent independent dosimetry testing (real and sham), provided by Litecure, Inc. (Newark, DE). None of the funding sources had any involvement in the study design; in the collection, analysis, or interpretation of study data; in the writing of the report; or in the decision to submit the article for publication.
Funding Information:
Dr. Mischoulon has received research support from the FisherWallace, Nordic Naturals, Methylation Sciences, Inc. (MSI), and PharmoRx Therapeutics. He has received honoraria for speaking from the Massachusetts General Hospital Psychiatry Academy. He has received royalties from Lippincott Williams & Wilkins for published book ‘‘Natural Medications for Psychiatric Disorders: Considering the Alternatives.’’ Dr. Katnani: Research funding from NINDS 5R01NS 086422.
PY - 2018/12
Y1 - 2018/12
N2 - 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 end-point, 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.
AB - 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 end-point, 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.
KW - depression
KW - low-level laser therapy
KW - randomized controlled trial
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U2 - 10.1089/pho.2018.4490
DO - 10.1089/pho.2018.4490
M3 - Article
AN - SCOPUS:85053529628
VL - 36
SP - 634
EP - 646
JO - Photomedicine and Laser Surgery
JF - Photomedicine and Laser Surgery
SN - 1549-5418
IS - 12
ER -