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NCT Number: NCT07111390

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major MDD Major Depressive Disorder Major Depressive Episode Mental Disorders Mood Disorders

Age range

24 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10017, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

60Hz Intermittent Light Therapy

Device

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

Sham light therapy

Device

Constant white light delivered via a wearable headset.

Primary outcomes

  1. Proportion of Participants who Complete all Scheduled Sessions

    Time frame: Up to Week 3

    Measure of retention; 15 sessions scheduled in total.

  2. Average Percentage of Completed Sessions

    Time frame: Up to Week 3

    Measure of adherence; 15 sessions scheduled in total.

  3. Proportion of Participants who Discontinue due to Adverse Effects

    Time frame: Up to Week 3

    Measure of tolerability.

Secondary outcomes

  1. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score

    Time frame: Baseline, Week 3

    The MADRS is a 10-item assessment of depression; each item is rated on a 7-point scale from 0 to 6. The total score is the sum of responses and ranges from 0 to 60; higher scores indicate greater severity of depression.

  2. Change in Hamilton Depression Rating Scale (HDRS-17) Score

    Time frame: Baseline, Week 3

    The HDRS-17 is a 17-item scale assessing the severity of depression. Most items are rated on a 5-point scale (0-4), with some using a 3-point scale (0-2). The total score is the sum of responses and ranges from 0-52; higher scores indicate greater severity of depression.

  3. Change in Patient Health Questionnaire (PHQ-9) Score

    Time frame: Baseline, Week 3

    The PHQ-9 is a 9-item scale assessing the prevalence of depressive symptoms. Each item is rated on a 4-point Likert scale from 0 to 3. The total score is the sum of responses and ranges from 0-27; higher scores indicate greater prevalence of depressive symptoms.

  4. Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) Score

    Time frame: Baseline, Week 3

    The QIDS-SR is a 15-item scale assessing depressive symptoms over the previous 7 days. Each item is rated on a 4-point Likert scale from 0 to 3. The total score is the sum of responses and ranges from 0-45; higher scores indicate greater prevalence of depressive symptoms.

  5. Change in Work and Social Adjustment Scale (WSAS) Score

    Time frame: Baseline, Week 3

    The WSAS is a 5-item scale assessing the impact of mental health on daily activities. Each item is rated on a 9-point Likert scale from 0 to 8. The total score is the sum of responses and ranges from 0-40; higher scores indicate more severe impairment on daily activities.

  6. Change in Generalized Anxiety Disorder (GAD-7) Score

    Time frame: Baseline, Week 3

    The GAD-7 is a 7-item scale assessing the severity of generalized anxiety disorder. Each item is rated on a scale from 0 to 3. The total score is the sum of responses and ranges from 0-21 with higher scores indicating more severe anxiety.

  7. Post-Study System Usability Questionnaire (PSSUQ) Score

    Time frame: Week 3

    The PSSUQ assesses the overall usability of the intervention; each of the 16 items is rated on a scale from 1-7. The total score is the sum of responses and ranges from 16 to 112; higher scores indicate greater usability of the intervention.

  8. System Usability Scale (SUS) Score

    Time frame: Week 3

    The SUS is a 10-item assessment of the usability of the intervention; the items are rated on a scale from 1-5. The total score is the sum of responses and ranges from 10 to 50; higher scores indicate greater usability of the intervention.

  9. Net Promoter Score (NPS)

    Time frame: Week 3

    The NPS is a single-item questionnaire asking participants how likely they are to recommend the intervention to a colleague. The total score ranges from 1-10; higher scores indicate greater likelihood of promoting the intervention.

  10. Brief Blinding Questionnaire (BBQ) Score

    Time frame: Week 3

    After completing the intervention phase of the study, effectiveness of participant blinding will be assessed using a 3-item questionnaire. The outcome will be scored as the percentage of participants who correctly guess their blinding assignment.

  11. Adverse Events

    Time frame: Week 3

    Incidence of spontaneously reported adverse events during the intervention period. Incidence and type will be reported in the "Adverse Events" section of the results.

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppina Pilloni

CONTACT

[email protected]

929-455-5317

Shayna Pehel

CONTACT

[email protected]

929-455-5104

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Syntropic Medical

Registry information

Official study title

A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 8, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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