Recruiting

60Hz Light Therapy

Sponsor:

NYU Langone Health

Code:

NCT07111390

Conditions

Depression

MDD

Major Depressive Disorder

Major Depressive Episode

Eligibility Criteria

Sex: All

Age: 24 - 65

Healthy Volunteers: Not accepted

Interventions

60Hz Intermittent Light Therapy

Sham Light Therapy

Study Details

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.

Conditions

Depression

MDD

Major Depressive Disorder

Major Depressive Episode

Study ID

NCT07111390

Start date

Aug 18, 2025

Status verified date

Jun, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 24 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Home-Based Intermittent Light Therapy

Adults with a major depressive episode (MDE) randomized to receive active home-based 60Hz intermittent light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions.

sham comparator: Sham Home-Based Light Therapy

Adults with a major depressive episode (MDE) randomized to receive sham home-based light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions.

Interventions

60Hz Intermittent Light Therapy

Intermittent 60 Hz flickering white light delivered via a wearable headset.

Sham Light Therapy

Constant white light delivered via a wearable headset.

Primary outcome measure

  • Proportion of Participants who Complete all Scheduled Sessions [ Time Frame: Up to Week 3 ]
  • Average Percentage of Completed Sessions [ Time Frame: Up to Week 3 ]
  • Proportion of Participants who Discontinue due to Adverse Effects [ Time Frame: Up to Week 3 ]

Central Contacts and Locations

Central contacts

Shayna Pehel

929-455-5104Shayna.Pehel@nyulangone.org

Giuseppina Pilloni

929-455-5317Giuseppina.Pilloni@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10017

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Brain stimulation
  • MDD
  • Depression
  • Light therapy
  • Wearable
  • Neuromodulation
  • Telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-29.