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

NCT07111390 | Recruiting FDA Device

• 1 other identifier: 25-00522
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Brain stimulation; MDD; Depression; Light therapy; Wearable; Neuromodulation; Telehealth

Outcome Measures

Primary Outcomes (3)

• Proportion of Participants who Complete all Scheduled Sessions

  Measure of retention; 15 sessions scheduled in total.

  Up to Week 3

• Average Percentage of Completed Sessions

  Measure of adherence; 15 sessions scheduled in total.

  Up to Week 3

• Proportion of Participants who Discontinue due to Adverse Effects

  Measure of tolerability.

  Up to Week 3

Secondary Outcomes (11)

• Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score

  Baseline, Week 3

• Change in Hamilton Depression Rating Scale (HDRS-17) Score

  Baseline, Week 3

• Change in Patient Health Questionnaire (PHQ-9) Score

  Baseline, Week 3

• Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) Score

  Baseline, Week 3

• Change in Work and Social Adjustment Scale (WSAS) Score

  Baseline, Week 3

Study Arms (2)

Active Home-Based Intermittent Light Therapy

EXPERIMENTAL

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.

Device: 60Hz Intermittent Light Therapy

Sham Home-Based Light Therapy

SHAM COMPARATOR

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.

Device: Sham Light Therapy

Interventions

60Hz Intermittent Light Therapy DEVICE

Intermittent 60 Hz flickering white light delivered via a wearable headset.

Active Home-Based Intermittent Light Therapy

Sham Light Therapy DEVICE

Constant white light delivered via a wearable headset.

Sham Home-Based Light Therapy

Eligibility Criteria

• Age: 24 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Syntropic Medical: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10017, United States

RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Giuseppina Pilloni, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shayna Pehel

CONTACT

929-455-5104; Shayna.Pehel@nyulangone.org

Giuseppina Pilloni

CONTACT

929-455-5317; Giuseppina.Pilloni@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: August 18, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)