Life sciences · Interventional Study
ClinicalTrials.gov · November 5, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07111390). This is a study registration, not published results. Lead sponsor: NYU Langone Health. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 44 participants (ACTUAL). Conditions: Depression, MDD, Major Depressive Disorder, Major Depressive Episode. Interventions: DEVICE: 60Hz Intermittent Light Therapy; DEVICE: Sham Light Therapy. Primary outcome measures: Proportion of Participants who Complete all Scheduled Sessions , Up to Week 3; Average Percentage of Completed Sessions , Up to Week 3; Proportion of Participants who Discontinue due to Adverse Effects , Up to Week 3. Brief summary: This pilot study evaluates the feasibility, safety, and preliminary efficacy of home-based 60Hz intermittent light therapy in adults with a major depressive episode (MDE). Participants will be randomized in a 2:1 ratio to receive either active or sham 60Hz intermittent light stimulation for 30 minutes daily (Monday through Friday) over three weeks. The light is delivered through a wearable headset. Clinical assessments will be conducted remotely at baseline, mid-point, post-treatment, and follow-up to measure changes in depressive symptoms.