Phase
Condition
Depression (Major/severe)
Depression
Affective Disorders
Treatment
Sham Light Therapy
60Hz Intermittent Light Therapy
Clinical Study ID
Ages 24-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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-17screening.
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 thesubjects' clinical care, and who is available for contact in case of increasedsubject 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
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 judgmentand 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 mayinterfere with light exposure.
Regular use of anti-inflammatory drugs or anticoagulants (e.g., clopidogrel).
Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the studyperiod, or breastfeeding
Study Design
Study Description
Connect with a study center
NYU Langone Health
New York, New York 10017
United StatesSite Not Available
NYU Langone Health
New York 5128581, New York 5128638 10017
United StatesActive - Recruiting

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