Actively Recruiting
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Led by NYU Langone Health · Updated on 2025-08-26
40
Participants Needed
1
Research Sites
27 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
S
Syntropic Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 of 17 or higher at screening
- Stable dose of antidepressant medication for at least 30 days prior to screening
- No premorbid cognitive impairment shown by a WRAT-5 Reading Recognition Subtest score above 85
- Access to a local healthcare provider responsible for clinical care and available for contact
- Ability to provide informed consent and comply with study procedures
- Access to a quiet space suitable for home-based light therapy sessions
- English-speaking, as all study materials and assessments are in English
You will not qualify if you...
- Presence of primary neurological or autoimmune disorders
- Psychiatric comorbidities such as anxiety, OCD, PTSD, bipolar disorder, or psychotic disorders
- Current or recent diagnosis of alcohol or substance use disorder
- History of bipolar disorder or any psychotic disorder
- Clinically significant suicidal thoughts or behaviors
- History of seizure disorder or epilepsy
- History of migraine, tinnitus, or photosensitivity
- Retinal disease, cataract, or other vision problems interfering with light exposure
- Regular use of anti-inflammatory drugs or anticoagulants like clopidogrel
- Currently pregnant, planning pregnancy during the study, or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10017
Actively Recruiting
Research Team
S
Shayna Pehel
CONTACT
G
Giuseppina Pilloni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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