Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
NCT ID: NCT07111390
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-08-18
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
60Hz Intermittent Light Therapy
Intermittent 60 Hz flickering white light delivered via a wearable headset.
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.
Sham Light Therapy
Constant white light delivered via a wearable headset.
Interventions
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60Hz Intermittent Light Therapy
Intermittent 60 Hz flickering white light delivered via a wearable headset.
Sham Light Therapy
Constant white light delivered via a wearable headset.
Eligibility Criteria
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Inclusion Criteria
* 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 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
24 Years
65 Years
ALL
No
Sponsors
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Syntropic Medical
UNKNOWN
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Giuseppina Pilloni, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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25-00522
Identifier Type: -
Identifier Source: org_study_id
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