Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Recruiting · NCT07111390 · Interventional (participants receive a specific treatment) · Lead sponsor: NYU Langone Health
View the official record on ClinicalTrials.gov →Interventions studied
60Hz Intermittent Light TherapySham Light Therapy
What this trial is about
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.
Who can take part
Age range
24 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- NYU Langone Health - New York, New York, United States