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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
24 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 weeks
  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether home light therapy is practical, safe, and may help adults with major depression. A headset gives flashing light at 60 flashes per second. Participants are assigned by chance to active or sham (comparison) treatment for 30 minutes each weekday for three weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 24 to 65 years old.
  • Have major depressive disorder confirmed by a study interview.
  • Score at least 17 on the study’s depression rating scale.
  • Have taken the same dose of an antidepressant for at least 30 days before depression screening.
  • Have no signs of thinking or memory problems before the illness, with a reading test score above 85.
  • Have a local health care provider responsible for your care who can be contacted if depression raises safety concerns.
  • Be able to understand and agree to join, follow study steps, and speak English.
  • Have a quiet space at home for light treatment sessions.

Who can't join

  • Have a main illness affecting the brain or nerves, or an autoimmune illness, where the body attacks its own tissues.
  • Have another mental health disorder found in the study interview, such as anxiety, OCD, or PTSD; or any history of bipolar disorder or a psychotic disorder, which can affect your sense of reality.
  • Have a current or recent alcohol or drug use disorder.
  • Have suicidal thoughts or actions that the study clinician judges to be a serious concern.
  • Have a history of seizures or epilepsy.
  • Have a history of migraines, tinnitus (ringing in the ears), or sensitivity to light.
  • Have retinal disease (damage at the back of the eye), cataracts (cloudy eye lenses), or other vision problems that may affect light treatment.
  • Regularly take anti-inflammatory drugs or medicines that prevent blood clots; or are pregnant, planning pregnancy during the study, or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NY