No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
24 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
NYU Langone Health · Other
Who this trial is looking for
This trial is looking for adults with major depression. Participants will use a special light therapy device at home for 30 minutes daily for three weeks. They will also have remote check-ins to discuss their symptoms.
Are You a Good Fit for This Trial?
Must be takingAntidepressants
Rules you outBipolar disorderPsychotic disorderSeizure disorderAlcohol use disorderSubstance use disorder
You may be able to join if
I am between 24 and 65 years old.
I have been diagnosed with Major Depressive Disorder.
I scored 17 or higher on the Hamilton Depression Rating Scale.
I have been on the same antidepressant medication for at least 30 days.
I can provide informed consent and follow study procedures.
I have a quiet space at home for light therapy.
I speak English.
You may not be able to join if
I have a primary neurological or autoimmune disorder.
I have other serious mental health conditions.
I have had an alcohol or substance use disorder recently.
I have a history of bipolar disorder or psychosis.
I have serious thoughts of harming myself.
I have a history of seizures or epilepsy.
I experience migraines or sensitivity to light.
I am currently pregnant, planning to become pregnant, or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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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…
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
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