A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression
Sponsor: NYU Langone Health
Trial Details
| Condition | Depression, MDD, Major Depressive Disorder, Major Depressive Episode |
| Intervention | 60Hz Intermittent Light Therapy; Sham Light Therapy |
| Phase | NA |
| Status | Recruiting |
| Participants | 40 |
| Est. Completion | 1 Jan 2027 |
| Last Updated | 29 June 2026 |
Primary Outcome
Proportion of Participants who Complete all Scheduled Sessions; Average Percentage of Completed Sessions; Proportion of Participants who Discontinue due to Adverse Effects
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * Age between 24 and 65 years (inclusive)\*. * Confirmed diagnosis of Major Depressive Disorder (MDD), based on MINI interview. * Hamilton Depression Rating Scale (HDRS-17) score ≥17 at screening. * On a stable dose of antidepressant medication for at least 30 days prior to HDRS-17 screening. * No evidence of premorbid cognitive impairment, as demonstrated by a standard score \>85 on the WRAT-5 Reading Recognition Subtest. * Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms. * Able to provide informed consent and comply with study procedures. * Access to a quiet space suitable for home-based light stimulation sessions. * English speaking: All study materials and assessments are only validated in English Exclusion Criteria: * Presence of primary neurological or autoimmune disorders. * Presence of psychiatric comorbidities as determined by the MINI interview (e.g., anxiety disorders, OCD, PTSD, bipolar disorder, psychotic disorder). * Current or recent diagnosis of alcohol or substance use disorder. * History of bipolar disorder or any psychotic disorder. * Clinically significant suicidal ideation or behavior, based on clinician judgment and the Columbia-Suicide Severity Rating Scale (C-SSRS). * History of seizure disorder or epilepsy. * History of migraine, tinnitus, or photosensitivity. * Diagnosis of retinal disease, cataract, or other visual impairments that may interfere with light exposure. * Regular use of anti-inflammatory drugs or anticoagulants (e.g., clopidogrel). * Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding
Trial Sites
Countries
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