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.
Age
24–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
