11/01/2026
𝐓𝐨𝐥𝐞𝐫𝐚𝐛𝐢𝐥𝐢𝐭𝐲 𝐚𝐧𝐝 𝐒𝐚𝐟𝐞𝐭𝐲 𝐨𝐟 𝐓𝐫𝐚𝐧𝐬𝐜𝐫𝐚𝐧𝐢𝐚𝐥 𝐏𝐡𝐨𝐭𝐨𝐛𝐢𝐨𝐦𝐨𝐝𝐮𝐥𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐌𝐨𝐨𝐝 𝐚𝐧𝐝 𝐀𝐧𝐱𝐢𝐞𝐭𝐲 𝐃𝐢𝐬𝐨𝐫𝐝𝐞𝐫𝐬
Cassano, et.al.
Introduction: Mood and anxiety disorders are a prevalent and significant leading cause of years lived with a disability worldwide. Existing antidepressants drugs are only partially effective, having burdensome side effects. One-third of patients do not achieve remission after several adequate antidepressant trials, and relapses of depression are frequent. Existing FDA-approved, device-based interventions are either invasive or only administered in the office. Transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light may be a promising treatment option for mood and anxiety disorders. Due to its low cost, and ease of self-administration, t-PBM has the potential to become widely accessible. The safety profile of t-PBM is a relevant factor for widespread use and administration.
Aim: To further investigate the t-PBM safety profile, this study aims to evaluate the tolerability and safety of t-PBM for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD).
Method: We completed a systematic analysis of the side effects from repeated sessions of t-PBM in three studies: an open-label study for GAD (LIGHTEN GAD) and two randomized control studies for MDD (ELATED-2; ELATED-3). Overall, 80 subjects were studied.
Result: Our results show that a low dose of NIR per t-PBM session can be administered with increasing frequency (up to daily sessions) and for several weeks (up to 12 weeks) without a corresponding increase in the occurrence or severity of adverse events. Additionally, there were no significant predictors for the variance in the number of reported adverse events (such as age, s*x or diagnosis).
Conclusion: The literature indicates that higher dosages of transcranial NIR could lead to greater antidepressant and anxiolytic effects; this study did not find any correlation between the increasing number of t-PBM sessions and the occurrence of adverse events.
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For the research, visit https://www.mdpi.com/2304-6732/9/8/507