NCT07111390Recruiting
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
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 1 Aug 2025
- Start date
- 18 Aug 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- NYU Langone Health
- Diseases
- Depression
- NCT number
- NCT07111390
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 18 Aug 2025 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Regular use of anti-inflammatory drugs or anticoagulants (e.g., clopidogrel).
Other illness
- 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.
- 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.
Other
- Clinically significant suicidal ideation or behavior, based on clinician judgment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding
Who the study is looking for
- 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
Age in the registry: 24 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.