NCT07111390 Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
| NCT ID | NCT07111390 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-18 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-08-18 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Giuseppina Pilloni, PhD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT07111390 clinical trial?
This trial is open to participants of all sexes, aged 24 Years or older, up to 65 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07111390 currently recruiting?
Yes, NCT07111390 is actively recruiting participants. Contact the research team at Shayna.Pehel@nyulangone.org for enrollment information.
Where is the NCT07111390 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07111390 clinical trial?
NCT07111390 is sponsored by NYU Langone Health. The principal investigator is Giuseppina Pilloni, PhD at NYU Langone Health. The trial plans to enroll 40 participants.
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