💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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