Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)

NYU Langone Health

Status: Enrolling

Conditions: Major Depressive Disorder; Major Depressive Episode; Depression; MDD

Treatments: Device: 60Hz Intermittent Light Therapy; Device: Sham Light Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07111390

25-00522

Details and patient eligibility

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 24 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Active Home-Based Intermittent Light Therapy

Experimental group

Description:

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.

Treatment:

Device: 60Hz Intermittent Light Therapy

Sham Home-Based Light Therapy

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Light Therapy