Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression
NYU Langone Health
40 participants
Aug 18, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 Criteria10
- 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
Interventions
Intermittent 60 Hz flickering white light delivered via a wearable headset.
Constant white light delivered via a wearable headset.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07111390