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Randomized Controlled Trial
. 2025 May 1:376:325-332.
doi: 10.1016/j.jad.2025.02.031. Epub 2025 Feb 15.

Violet light photobiomodulation therapy for depression: A double-blind randomized crossover trial

Yoshihiro Noda  1 , Keita Taniguchi  2 , Mayuko Takano  2 , Yu Mimura  2 , Naotake Yanagisawa  3 , Motoshi Hayano  4 , Ryosuke Kitahata  5 , Yoko Ogawa  6 , Masaru Mimura  7 , Kazuo Tsubota  8
Affiliations
Randomized Controlled Trial

Violet light photobiomodulation therapy for depression: A double-blind randomized crossover trial

Yoshihiro Noda et al. J Affect Disord. .

Abstract

Background: Medication-supplemented psychotherapy is the primary treatment for mild major depressive disorder (MDD). However, limited resources and patient non-adherence present challenges, necessitating innovative and less burdensome interventions. This study aimed to compare the effectiveness of active and placebo violet light irradiation goggles for treating mild MDD.

Methods: The present study was a randomized, double-blind, placebo-controlled trial with a crossover design conducted at the Shinjuku-Yoyogi Mental Lab Clinic between June 2021 and December 2023. A total of 57 Japanese outpatients aged 20-74 years diagnosed with mild MDD were randomly assigned to use active or placebo 40-Hz violet light irradiation goggles for 4 weeks by adaptive allocation. Each participant wore their goggles for 4 weeks with 4-week washout intervals, while their medications for depression remained unchanged. The primary endpoints were the changes in the Montgomery-Åsberg Depression Rating Scale score (Phases I and II) 4 weeks after wearing the active and placebo goggles and differences between the group's scores. The safety of the violet light irradiation goggles was also investigated.

Results: The Montgomery-Åsberg Depression Rating Scale scores of the participants who wore active violet light irradiation goggles significantly improved compared with those of their counterparts, who wore placebo goggles (95 % confidence interval: -2.5 to -0.1; p = 0.042). No adverse events related to wearing the violet light irradiation goggles were observed.

Conclusions: Violet light irradiation goggles are non-invasive and may be effective for treating mild MDD. Neuromodulation of the depression network via OPN5 by violet light may contribute to the anti-depressant effects.

Trial registration: Japan Registry of Clinical Trials (jRCTs032210260; https://jrct.niph.go.jp/latest-detail/jRCTs032210260).

Keywords: Depression; Mild major depressive disorder; Photobiomodulation therapy; Randomized, double-blind clinical trial; Violet light irradiation goggles.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: YN received a Grant-in-Aid for Scientific Research (B) (21H02813) from the Japan Society for the Promotion of Science (JSPS), research grants from the Japan Agency for Medical Research and Development (AMED), and investigator-initiated clinical study grants from Teijin Pharma Ltd. and Inter-Reha Co., Ltd. He also received a research grant from the Watanabe Foundation and the Daiichi Sankyo Scholarship Donation Program. He has received speaker honoraria from Sumitomo Pharma Co., Ltd., Teijin Pharma Ltd., Takeda Pharmaceutical Co., Ltd., Lundbeck Japan Co., Ltd., and Viatris Inc. within the past 3 years, outside the submitted work. He also received equipment-in-kind support for an investigator-initiated study from Magventure Inc., Inter-Reha Co., Ltd., and Miyuki Giken Co., Ltd. MM has received speaker honoraria from Biogen Japan, Byer Pharmaceutical, Daiichi Sankyo, Dainippon Sumitomo Pharma, Demant Japan, Eisai, Eli Lilly, Fuji Film RI Pharma, and Hisamitsu Pharmaceuticals. KT reports on his position as the CEO of Tsubota Laboratory, Inc., and the founder and shareholder of the company. Tsubota Lab holds IP: WO2020/027305 for the device and method described in this study. The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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