Rationale and design of a double-blinded, randomized placebo-controlled trial of 40 Hz light neurostimulation therapy for depression (FELIX)
ABSTRACT
BACKGROUND: Major depressive disorder (MDD) affects over 300 million people globally, and current treatments rely on trial-and-error. Reliable biomarkers are needed for more informed and personalized treatment solutions. Gamma-frequency brainwaves (30-80 Hz) are potential biomarkers linked to neuropsychiatric conditions, including MDD. Previous studies have shown neuroprotective effects using rhythmic light and sound stimuli in Alzheimer’s disease (AD) patients and animal models. This trial aims to investigate the antidepressant, cognitive, and electrophysiological effects of a novel light therapy approach using 40 Hz masked flickering light for patients diagnosed with MDD.
METHODS AND DESIGN: Sixty patients with a current diagnosis of a major depressive episode will be enrolled in a randomized, double-blinded, placebo-controlled trial. The active treatment group will receive 40 Hz masked flickering light stimulation, while the control group will receive continuous light matched in color temperature and brightness. Patients in both groups will receive daily light treatment at home and attend four follow-up visits to assess depression symptoms, cognitive function, quality of life, sleep, and electroencephalographic changes. The primary endpoint is the mean change from baseline to week 6 in depression severity (HAM-D6 subscale) between the groups.
PMID: 38767238 | DOI: 10.1080/07853890.2024.2354852
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