Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Purpose
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
- Depression
- MDD
- Major Depressive Disorder
- Major Depressive Episode
Eligibility
- Eligible Ages
- Between 24 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Active Home-Based Intermittent Light Therapy |
Adults with a major depressive episode (MDE) randomized to receive active home-based 60Hz intermittent light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions. |
|
|
Sham Comparator Sham Home-Based Light Therapy |
Adults with a major depressive episode (MDE) randomized to receive sham home-based light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- NYU Langone Health
Detailed Description
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.
