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Search / Trial NCT07111390

Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)

Launched by NYU LANGONE HEALTH · Aug 1, 2025

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

Brain Stimulation Mdd Depression Light Therapy Wearable Neuromodulation Telehealth

ClinConnect Summary

This clinical trial is exploring a new treatment for adults with Major Depressive Disorder (MDD), a type of depression. The study is testing whether using a special light therapy at home can be safe, practical, and helpful in reducing depressive symptoms. The light therapy involves wearing a headset that delivers brief pulses of light at a specific frequency (60Hz) for 30 minutes each day, Monday through Friday, over three weeks. Some participants will receive the real light treatment, while others will get a placebo version that looks similar but doesn’t provide the active light. Researchers will check participants’ mood and symptoms remotely before, during, and after the treatment to see if it makes a difference.

To join the study, participants need to be between 24 and 65 years old and have a confirmed diagnosis of Major Depressive Disorder with moderate to severe symptoms. They should be on a stable antidepressant medication for at least a month and not have other serious medical or psychiatric conditions like bipolar disorder, seizures, or vision problems. Participants must also have access to a quiet place at home for the therapy sessions and be able to communicate in English. Throughout the study, participants will be monitored remotely, and their safety will be carefully watched. This trial is not yet recruiting, but it offers a potential new way to manage depression that can be done comfortably at home.

Gender

ALL

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

About Nyu Langone Health

NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Giuseppina Pilloni, PhD

Principal Investigator

NYU Langone Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported