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

Last updated: August 25, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression (Major/severe)

Depression

Affective Disorders

Treatment

Sham Light Therapy

60Hz Intermittent Light Therapy

Clinical Study ID

NCT07111390
25-00522
  • Ages 24-65
  • All Genders

Study 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

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-17screening.

  • 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 thesubjects' clinical care, and who is available for contact in case of increasedsubject 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

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 judgmentand 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 mayinterfere with light exposure.

  • Regular use of anti-inflammatory drugs or anticoagulants (e.g., clopidogrel).

  • Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the studyperiod, or breastfeeding

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Sham Light Therapy
Phase:
Study Start date:
August 18, 2025
Estimated Completion Date:
March 01, 2026

Study Description

This pilot study will evaluate the tolerability, usability, and preliminary impact of a novel wearable device delivering 60Hz intermittent light for treatment of depressive symptoms in adults with MDD. All procedures are conducted remotely.

Connect with a study center

  • NYU Langone Health

    New York, New York 10017
    United States

    Site Not Available

  • NYU Langone Health

    New York 5128581, New York 5128638 10017
    United States

    Active - Recruiting

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